Back to resultsEffects of GTS-21 on Smoking Behavior and Neurocognitive Functions
Primary Purpose
Tobacco Use Disorder
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GTS-21
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking, Smoking Cessation
Eligibility Criteria
Inclusion Criteria:
- Minimum of 12 years of education
- Must report typical daily smoking of > 10 cigarettes/day over the previous year
- Must report a history of at least 3 years of regular smoking
- Must provide carbon monoxide measures of at least 6.5 ppm
- Must report a willingness to quit smoking
Exclusion Criteria:
- Participants engaged in behavioral and/or nicotine replacement therapies, or assisted quit efforts, within previous 6 months.
- Must not meet criteria for other substance dependence or major psychiatric disorders.
- Must be absent chronic medical conditions that might jeopardize health and safety, confound data interpretation or that contraindicate the administration of compounds acting at nAChR sites. This list includes disorders with direct effects on neurologic function (e.g., seizure disorders, transient ischemic events, chronic or active hepatic disease), metabolic disorders (e.g., uncontrolled Type 2 diabetes), or cardiovascular disease (e.g., hypertension, mitral valve compromise, tachycardia, or irregular heart rates).
- Must not smoke only cigars, pipes or hookahs or use nicotine products but not cigarettes
- Must not report current use of nicotine replacement therapies (i.e., occasions of > 4 h/week during a typical week, even if not used as a cessation aid)
- Must not have used bupropion within the previous year
- Must not report any past use (regardless of year) of varenicline
- Women may not be breastfeeding, pregnant or intending to become pregnant during the study period
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
GTS-21
Placebo
Arm Description
Participants in the GTS-21 arm will receive 150 mg/BID GTS-21 over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
Participants in the Placebo arm will receive placebo compound twice daily over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
Outcomes
Primary Outcome Measures
Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
Nicotine use will be assessed using Timeline Followback procedures. Nicotine use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.
Change in Carbon Monoxide (CO) from baseline at weeks 5, 8
Expired Carbon Monoxide levels will be quantified in parts per million.
Change in Urine Cotinine (COT) from baseline at weeks 5, 8
Cotinine excreted in urine will be quantified in ng/mL
Secondary Outcome Measures
Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 8
The Beck Depression Inventory will be used to quantify depressive symptomatology. The measure is a 21-item, self-report, multiple-choice inventory, with scores ranging from 0-63.
Change in State Anxiety Inventory (AI) from baseline at weeks 5, 8
The State Anxiety Inventory will be used to quantify anxiety symptomatology. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80.
Change in State Anger (ANG-S) from baseline at weeks 5, 8
The Spielberger State Anger Inventory will be used to assess state anger. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80.
Pill Count - Week 1
Medication compliance will be assessed with pill counts.
Pill Count - Week 5
Medication compliance will be assessed with pill counts.
Pill Count - Week 8
Medication compliance will be assessed with pill counts.
Change in Minnesota Withdrawal Scale from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
The Minnesota Withdrawal Scale measures self-reported severity of nicotine withdrawal. The measure has 15 items, with five possible responses (0-5), thus scores on the scale range from 0 to 60.
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 1
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 2
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 3
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 4
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 5
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 6
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 7
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 8
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Change in Profile of Mood States 2-A from Baseline at Week 1, 2, 3, 4, 5, 6, 7, 8
The Profile of Mood States-2 (short-form for adults) The POMS 2 is a multi-dimensional, assessment of transient moods, and states of affect. The measure includes 35 items, each rated on a 5-point scale (0-4).
Rapid Visual Information Processing task (Behavior) - Baseline
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include accuracy and reaction time.
Rapid Visual Information Processing task - (Behavior) - Week 8
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include accuracy and reaction time.
Rapid Visual Information Processing task - (EEG) - Baseline
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Rapid Visual Information Processing task - (EEG) - Week 8
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Measurement of GTS-21 Concentration in Blood - Week 5
Blood samples will be collected and analyzed for their concentration of GTS-21.
Measurement of GTS-21 Concentration in Blood - Week 8
Blood samples will be collected and analyzed for their concentration of GTS-21.
Trail Making Test A (TMT-A) - Baseline
The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.
Trail Making Test A (TMT-A) - Week 5
The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.
Trail Making Test A (TMT-A) - Week 8
The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.
Trail Making Test B (TMT-B) - Baseline
The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.
Trail Making Test B (TMT-B) - Week 5
The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.
Trail Making Test B (TMT-B) - Week 8
The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.
N-Back Working Memory Task (Behavior) - Baseline
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include accuracy and reaction time.
N-Back Working Memory Task (Behavior) - Week 8
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include accuracy and reaction time.
N-Back Working Memory Task (EEG) - Baseline
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
N-Back Working Memory Task (EEG) - Week 8
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Simple Reaction Time Test - Baseline
In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.
Simple Reaction Time Test - Week 5
In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.
Simple Reaction Time Test - Week 8
In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.
Little Man Test - Baseline
In this computerized mental rotation test, subjects must indicate the hand in which a simulated figure holds an object. The dependent measures are accuracy and reaction time.
Little Man Test - Week 8
In this computerized mental rotation test, subjects must indicate the hand in which a simulated figure holds an object. The dependent measures are accuracy and reaction time.
Visual-Perceptual Analysis Test - Baseline
In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.
Visual-Perceptual Analysis Test - Week 5
In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.
Visual-Perceptual Analysis Test - Week 8
In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.
Wisconsin Card Sorting Test - Baseline
The Wisconsin Card Sort Test is a computerized task which requires subjects to match "cards" based on shifting matching rules which include color, shape, and number of symbols. The dependent measures for this task include accuracy and response time.
Wisconsin Card Sorting Test - Week 8
The Wisconsin Card Sort Test is a computerized task which requires subjects to match "cards" based on shifting matching rules which include color, shape, and number of symbols. The dependent measures for this task include accuracy and response time.
Sternberg Short-Term Memory Test - Baseline
The Sternberg Short-Term Memory Test is a computerized task in which participants are shown four digits, presented one at a time, followed by a probe digit. They must determine if the probe digit was in the original set of digits, and recall the digits. The dependent variables are probe accuracy, number of correct recalls, and time to completion.
Sternberg Short-Term Memory Test - Week 8
The Sternberg Short-Term Memory Test is a computerized task in which participants are shown four digits, presented one at a time, followed by a probe digit. They must determine if the probe digit was in the original set of digits, and recall the digits. The dependent variables are probe accuracy, number of correct recalls, and time to completion.
Stroop Color Word Task - Baseline
The Stroop Task is a measure of inhibitory control. Subjects are directed to name the colors words are printed in (i.e., "blue"), while ignoring the incongruent meaning of the words. The dependent measures include number correct and number completed.
Stroop Color Word Task - Week 8
The Stroop Task is a measure of inhibitory control. Subjects are directed to name the colors words are printed in (i.e., "blue"), while ignoring the incongruent meaning of the words. The dependent measures include number correct and number completed.
Digit Symbol Substitution Task - Baseline
The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.
Digit Symbol Substitution Task - Week 5
The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.
Digit Symbol Substitution Task - Week 8
The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.
Metabolic Panel - Baseline
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Metabolic Panel - Week 2
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Metabolic Panel - Week 5
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Metabolic Panel - Week 8
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Metabolic Panel - Week 9 (Followup)
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Urinalysis - Baseline
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Urinalysis - Week 2
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Urinalysis - Week 5
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Urinalysis - Week 8
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Urinalysis - Week 9 (Followup)
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Electrocardiogram - Baseline
Standard electrocardiographic data will be collected, including heart rate (BPM) and time between start of the Q wave and end of the T wave (QT interval).
Electrocardiogram - Week 1
Standard electrocardiographic data will be collected, including heart rate (BPM) and time between start of the Q wave and end of the T wave (QT interval).
Change in Reported Drug and Alcohol Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
Drug and alcohol use will be assessed using Timeline Followback procedures. Drug and alcohol use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.
Change in Blood Pressure from baseline at weeks 2, 5, 8, 9
Systolic and Diastolic pressures will be collected.
Full Information
NCT ID
NCT02432066
First Posted
April 28, 2015
Last Updated
March 21, 2019
Sponsor
University of Florida
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02432066
Brief Title
Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
Official Title
Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not started and participants were not enrolled
Study Start Date
September 29, 2018 (Anticipated)
Primary Completion Date
December 29, 2018 (Anticipated)
Study Completion Date
December 29, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Attempts to quit cigarette smoking are often accompanied by negative mood and problems in attention and memory. These effects, in turn, may contribute to smoking relapse. This exploratory/developmental project examines the effects of a novel medication, GTS-21, on individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and women who are chronic cigarette smokers.
Detailed Description
The project is a clinical trial assessing the effects of GTS-21 (an α7 nicotinic receptor partial agonist) on smoking, mood, neurocognition, and neurophysiology, in a small sample of chronic smokers who are currently healthy and interested in smoking cessation. Using a double-blind, placebo controlled, parallel group design, 54 (27 women) community smokers who have demonstrated a readiness to quit will participate over a 7 week active trial. Subjects will be randomly assigned to active drug or placebo groups. Across the study period, participants will undergo repeated neurobehavioral testing, laboratory assessments of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood state and side-effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Smoking, Smoking Cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GTS-21
Arm Type
Active Comparator
Arm Description
Participants in the GTS-21 arm will receive 150 mg/BID GTS-21 over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in the Placebo arm will receive placebo compound twice daily over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
Intervention Type
Drug
Intervention Name(s)
GTS-21
Other Intervention Name(s)
3-(2,4-dimethoxybenzylidene) anabaseine (DMXB-A)
Intervention Description
GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Oral placebo pills, compounded by the UF investigational pharmacy
Primary Outcome Measure Information:
Title
Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
Description
Nicotine use will be assessed using Timeline Followback procedures. Nicotine use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.
Time Frame
Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Title
Change in Carbon Monoxide (CO) from baseline at weeks 5, 8
Description
Expired Carbon Monoxide levels will be quantified in parts per million.
Time Frame
Change in baseline at Week 5, Week 8
Title
Change in Urine Cotinine (COT) from baseline at weeks 5, 8
Description
Cotinine excreted in urine will be quantified in ng/mL
Time Frame
Change in baseline at Week 5, Week 8
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 8
Description
The Beck Depression Inventory will be used to quantify depressive symptomatology. The measure is a 21-item, self-report, multiple-choice inventory, with scores ranging from 0-63.
Time Frame
Change in baseline at Week 5, Week 8
Title
Change in State Anxiety Inventory (AI) from baseline at weeks 5, 8
Description
The State Anxiety Inventory will be used to quantify anxiety symptomatology. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80.
Time Frame
Change in baseline at Week 5, Week 8
Title
Change in State Anger (ANG-S) from baseline at weeks 5, 8
Description
The Spielberger State Anger Inventory will be used to assess state anger. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80.
Time Frame
Change in baseline at Week 5, Week 8
Title
Pill Count - Week 1
Description
Medication compliance will be assessed with pill counts.
Time Frame
Week 1
Title
Pill Count - Week 5
Description
Medication compliance will be assessed with pill counts.
Time Frame
Week 5
Title
Pill Count - Week 8
Description
Medication compliance will be assessed with pill counts.
Time Frame
Week 8
Title
Change in Minnesota Withdrawal Scale from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
Description
The Minnesota Withdrawal Scale measures self-reported severity of nicotine withdrawal. The measure has 15 items, with five possible responses (0-5), thus scores on the scale range from 0 to 60.
Time Frame
Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Title
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 1
Description
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Time Frame
Week 1
Title
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 2
Description
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Time Frame
Week 2
Title
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 3
Description
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Time Frame
Week 3
Title
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 4
Description
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Time Frame
Week 4
Title
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 5
Description
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Time Frame
Week 5
Title
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 6
Description
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Time Frame
Week 6
Title
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 7
Description
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Time Frame
Week 7
Title
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 8
Description
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Time Frame
Week 8
Title
Change in Profile of Mood States 2-A from Baseline at Week 1, 2, 3, 4, 5, 6, 7, 8
Description
The Profile of Mood States-2 (short-form for adults) The POMS 2 is a multi-dimensional, assessment of transient moods, and states of affect. The measure includes 35 items, each rated on a 5-point scale (0-4).
Time Frame
Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Title
Rapid Visual Information Processing task (Behavior) - Baseline
Description
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include accuracy and reaction time.
Time Frame
Baseline
Title
Rapid Visual Information Processing task - (Behavior) - Week 8
Description
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include accuracy and reaction time.
Time Frame
Week 8
Title
Rapid Visual Information Processing task - (EEG) - Baseline
Description
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Time Frame
Baseline
Title
Rapid Visual Information Processing task - (EEG) - Week 8
Description
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Time Frame
Week 8
Title
Measurement of GTS-21 Concentration in Blood - Week 5
Description
Blood samples will be collected and analyzed for their concentration of GTS-21.
Time Frame
Week 5
Title
Measurement of GTS-21 Concentration in Blood - Week 8
Description
Blood samples will be collected and analyzed for their concentration of GTS-21.
Time Frame
Week 8
Title
Trail Making Test A (TMT-A) - Baseline
Description
The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.
Time Frame
Baseline
Title
Trail Making Test A (TMT-A) - Week 5
Description
The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.
Time Frame
Week 5
Title
Trail Making Test A (TMT-A) - Week 8
Description
The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.
Time Frame
Week 8
Title
Trail Making Test B (TMT-B) - Baseline
Description
The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.
Time Frame
Baseline
Title
Trail Making Test B (TMT-B) - Week 5
Description
The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.
Time Frame
Week 5
Title
Trail Making Test B (TMT-B) - Week 8
Description
The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.
Time Frame
Week 8
Title
N-Back Working Memory Task (Behavior) - Baseline
Description
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include accuracy and reaction time.
Time Frame
Baseline
Title
N-Back Working Memory Task (Behavior) - Week 8
Description
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include accuracy and reaction time.
Time Frame
Week 8
Title
N-Back Working Memory Task (EEG) - Baseline
Description
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Time Frame
Baseline
Title
N-Back Working Memory Task (EEG) - Week 8
Description
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Time Frame
Week 8
Title
Simple Reaction Time Test - Baseline
Description
In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.
Time Frame
Baseline
Title
Simple Reaction Time Test - Week 5
Description
In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.
Time Frame
Week 5
Title
Simple Reaction Time Test - Week 8
Description
In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.
Time Frame
Week 8
Title
Little Man Test - Baseline
Description
In this computerized mental rotation test, subjects must indicate the hand in which a simulated figure holds an object. The dependent measures are accuracy and reaction time.
Time Frame
Baseline
Title
Little Man Test - Week 8
Description
In this computerized mental rotation test, subjects must indicate the hand in which a simulated figure holds an object. The dependent measures are accuracy and reaction time.
Time Frame
Week 8
Title
Visual-Perceptual Analysis Test - Baseline
Description
In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.
Time Frame
Baseline
Title
Visual-Perceptual Analysis Test - Week 5
Description
In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.
Time Frame
Week 5
Title
Visual-Perceptual Analysis Test - Week 8
Description
In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.
Time Frame
Week 8
Title
Wisconsin Card Sorting Test - Baseline
Description
The Wisconsin Card Sort Test is a computerized task which requires subjects to match "cards" based on shifting matching rules which include color, shape, and number of symbols. The dependent measures for this task include accuracy and response time.
Time Frame
Baseline
Title
Wisconsin Card Sorting Test - Week 8
Description
The Wisconsin Card Sort Test is a computerized task which requires subjects to match "cards" based on shifting matching rules which include color, shape, and number of symbols. The dependent measures for this task include accuracy and response time.
Time Frame
Week 8
Title
Sternberg Short-Term Memory Test - Baseline
Description
The Sternberg Short-Term Memory Test is a computerized task in which participants are shown four digits, presented one at a time, followed by a probe digit. They must determine if the probe digit was in the original set of digits, and recall the digits. The dependent variables are probe accuracy, number of correct recalls, and time to completion.
Time Frame
Baseline
Title
Sternberg Short-Term Memory Test - Week 8
Description
The Sternberg Short-Term Memory Test is a computerized task in which participants are shown four digits, presented one at a time, followed by a probe digit. They must determine if the probe digit was in the original set of digits, and recall the digits. The dependent variables are probe accuracy, number of correct recalls, and time to completion.
Time Frame
Week 8
Title
Stroop Color Word Task - Baseline
Description
The Stroop Task is a measure of inhibitory control. Subjects are directed to name the colors words are printed in (i.e., "blue"), while ignoring the incongruent meaning of the words. The dependent measures include number correct and number completed.
Time Frame
Baseline
Title
Stroop Color Word Task - Week 8
Description
The Stroop Task is a measure of inhibitory control. Subjects are directed to name the colors words are printed in (i.e., "blue"), while ignoring the incongruent meaning of the words. The dependent measures include number correct and number completed.
Time Frame
Week 8
Title
Digit Symbol Substitution Task - Baseline
Description
The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.
Time Frame
Baseline
Title
Digit Symbol Substitution Task - Week 5
Description
The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.
Time Frame
Week 5
Title
Digit Symbol Substitution Task - Week 8
Description
The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.
Time Frame
Week 8
Title
Metabolic Panel - Baseline
Description
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Time Frame
Baseline
Title
Metabolic Panel - Week 2
Description
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Time Frame
Week 2
Title
Metabolic Panel - Week 5
Description
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Time Frame
Week 5
Title
Metabolic Panel - Week 8
Description
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Time Frame
Week 8
Title
Metabolic Panel - Week 9 (Followup)
Description
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Time Frame
Week 9
Title
Urinalysis - Baseline
Description
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Time Frame
Baseline
Title
Urinalysis - Week 2
Description
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Time Frame
Week 2
Title
Urinalysis - Week 5
Description
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Time Frame
Week 5
Title
Urinalysis - Week 8
Description
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Time Frame
Week 8
Title
Urinalysis - Week 9 (Followup)
Description
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Time Frame
Week 9
Title
Electrocardiogram - Baseline
Description
Standard electrocardiographic data will be collected, including heart rate (BPM) and time between start of the Q wave and end of the T wave (QT interval).
Time Frame
Baseline
Title
Electrocardiogram - Week 1
Description
Standard electrocardiographic data will be collected, including heart rate (BPM) and time between start of the Q wave and end of the T wave (QT interval).
Time Frame
Week 1
Title
Change in Reported Drug and Alcohol Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
Description
Drug and alcohol use will be assessed using Timeline Followback procedures. Drug and alcohol use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.
Time Frame
Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Title
Change in Blood Pressure from baseline at weeks 2, 5, 8, 9
Description
Systolic and Diastolic pressures will be collected.
Time Frame
Change in baseline at Week 2, Week 5, Week 8, Week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Minimum of 12 years of education
Must report typical daily smoking of > 10 cigarettes/day over the previous year
Must report a history of at least 3 years of regular smoking
Must provide carbon monoxide measures of at least 6.5 ppm
Must report a willingness to quit smoking
Exclusion Criteria:
Participants engaged in behavioral and/or nicotine replacement therapies, or assisted quit efforts, within previous 6 months.
Must not meet criteria for other substance dependence or major psychiatric disorders.
Must be absent chronic medical conditions that might jeopardize health and safety, confound data interpretation or that contraindicate the administration of compounds acting at nAChR sites. This list includes disorders with direct effects on neurologic function (e.g., seizure disorders, transient ischemic events, chronic or active hepatic disease), metabolic disorders (e.g., uncontrolled Type 2 diabetes), or cardiovascular disease (e.g., hypertension, mitral valve compromise, tachycardia, or irregular heart rates).
Must not smoke only cigars, pipes or hookahs or use nicotine products but not cigarettes
Must not report current use of nicotine replacement therapies (i.e., occasions of > 4 h/week during a typical week, even if not used as a cessation aid)
Must not have used bupropion within the previous year
Must not report any past use (regardless of year) of varenicline
Women may not be breastfeeding, pregnant or intending to become pregnant during the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara J Nixon, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
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