Back to resultsAtomoxetine's Effects On Nicotine Response And Stress Response In Smokers
Primary Purpose
Nicotine Dependence
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring nicotine, smoking, atomoxetine, stress
Eligibility Criteria
Inclusion Criteria:
- female and male smokers, not treatment seeking, aged 18 to 55 years;
- history of smoking daily for the past 12 months, at least 5 cigarettes daily;
- CO level > 10ppm;
- for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Exclusion Criteria:
- history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment, coronary artery disease, cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
- regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year. We will make an exception for the following Axis I diagnoses: nicotine dependence and alcohol or other drug dependence (i.e., cocaine, opioid) as long as they are not meeting abuse or dependence criteria within the past 3 months for alcohol or drug use;
- use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
- known allergy to atomoxetine
Sites / Locations
- West Haven Veterans Affairs
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Atomoxetine
Arm Description
placebo
atomoxetine (40 mg/day)
Outcomes
Primary Outcome Measures
Nicotine Effects Questionnaire
Subjects will rate 6 items that are related to nicotine effect on a 100 mm scale, "not at all" to "extremely." The items are feeling the drug strength, feel "good" drug effects, feel "bad" drug effects, feel jittery, feel stimulated, and head rush. This instrument is an abbreviated version of a visual analog scale (VAS) and allows rapid detection of nicotine effects.
Nicotine Effects Questionnaire
Subjects will rate 6 items that are related to nicotine effect on a 100 mm scale, "not at all" to "extremely." The items are feeling the drug strength, feel "good" drug effects, feel "bad" drug effects, feel jittery, feel stimulated, and head rush. This instrument is an abbreviated version of a visual analog scale (VAS) and allows rapid detection of nicotine effects.
Secondary Outcome Measures
Center for Epidemiologic Studies Depression (CES-D) scale
The Center for Epidemiologic Studies Depression (CES-D) scale is a 20-item self-report measure of depressive symptoms. The range of scores is from 0 to 60, with higher scores reflecting increased depressive symptoms 41. The CES-D does not heavily depend on pathological items compared with other scales such as the Beck Depression Inventory and does not define clinical depression.
Positive and Negative Affect Schedule (PANAS )
Positive and Negative Affect Schedule (PANAS ) is a 20-item scale that assesses both negative and positive affective states. Subjects rate adjectives describing affective states on a scale of 1 to 5 using a specified time period (e.g., now, today, past week etc.). Scores are then added up to generate negative and positive scale scores.
The Profile of Mood States (POMS)
The Profile of Mood States (POMS) is a 72-item questionnaire which consists of adjectives commonly used to describe momentary mood states. It has been found to be sensitive to the mood-altering effects of drugs including nicotine. POMS has a 5-point objective rating scale (0=not at all to 5=extremely). There are eight mood states that this scale measures: (1) Anger, (2) Anxiety, (3) Confusion, (4) Depression, (5) Elation, (6) Fatigue, (7) Friendliness and (8) Vigor. POMS will be used during each session to measure effects of atomoxetine or nicotine on mood.
Center for Epidemiologic Studies Depression (CES-D) scale
The Center for Epidemiologic Studies Depression (CES-D) scale is a 20-item self-report measure of depressive symptoms. The range of scores is from 0 to 60, with higher scores reflecting increased depressive symptoms 41. The CES-D does not heavily depend on pathological items compared with other scales such as the Beck Depression Inventory and does not define clinical depression.
Positive and Negative Affect Schedule (PANAS )
Positive and Negative Affect Schedule (PANAS ) is a 20-item scale that assesses both negative and positive affective states 44. Subjects rate adjectives describing affective states on a scale of 1 to 5 using a specified time period (e.g., now, today, past week etc.). Scores are then added up to generate negative and positive scale scores.
The Profile of Mood States (POMS)
The Profile of Mood States (POMS) is a 72-item questionnaire which consists of adjectives commonly used to describe momentary mood states. It has been found to be sensitive to the mood-altering effects of drugs including nicotine. POMS has a 5-point objective rating scale (0=not at all to 5=extremely). There are eight mood states that this scale measures: (1) Anger, (2) Anxiety, (3) Confusion, (4) Depression, (5) Elation, (6) Fatigue, (7) Friendliness and (8) Vigor. POMS will be used during each session to measure effects of atomoxetine or nicotine on mood.
Symptom Checklist Form (SCF)
In order to monitor adverse events from the study medications, SCF will be administered before and after each session. SCF is a locally developed symptom checklist that includes possible side effects of study medications with each symptom being scored 1-5.
Symptom Checklist Form (SCF)
In order to monitor adverse events from the study medications, SCF will be administered before and after each session. SCF is a locally developed symptom checklist that includes possible side effects of study medications with each symptom being scored 1-5.
Nicotine Withdrawal Symptom Checklist (NWSC)
Smokers will be asked to rate several nicotine withdrawal symptoms on a likert scale visual analogue. There are 12 items responses range from 0, "not at all" to 3 "extremely".
Nicotine Withdrawal Symptom Checklist (NWSC)
Smokers will be asked to rate several nicotine withdrawal symptoms on a likert scale visual analogue. There are 12 items responses range from 0, "not at all" to 3 "extremely".
Full Information
NCT ID
NCT02046551
First Posted
January 23, 2014
Last Updated
May 19, 2017
Sponsor
Yale University
Collaborators
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02046551
Brief Title
Atomoxetine's Effects On Nicotine Response And Stress Response In Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
funding lost
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate atomoxetine's effects on the rewarding and reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the negative effects of nicotine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
nicotine, smoking, atomoxetine, stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Atomoxetine
Arm Type
Experimental
Arm Description
atomoxetine (40 mg/day)
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Nicotine Effects Questionnaire
Description
Subjects will rate 6 items that are related to nicotine effect on a 100 mm scale, "not at all" to "extremely." The items are feeling the drug strength, feel "good" drug effects, feel "bad" drug effects, feel jittery, feel stimulated, and head rush. This instrument is an abbreviated version of a visual analog scale (VAS) and allows rapid detection of nicotine effects.
Time Frame
Day 5
Title
Nicotine Effects Questionnaire
Description
Subjects will rate 6 items that are related to nicotine effect on a 100 mm scale, "not at all" to "extremely." The items are feeling the drug strength, feel "good" drug effects, feel "bad" drug effects, feel jittery, feel stimulated, and head rush. This instrument is an abbreviated version of a visual analog scale (VAS) and allows rapid detection of nicotine effects.
Time Frame
Day 17
Secondary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression (CES-D) scale
Description
The Center for Epidemiologic Studies Depression (CES-D) scale is a 20-item self-report measure of depressive symptoms. The range of scores is from 0 to 60, with higher scores reflecting increased depressive symptoms 41. The CES-D does not heavily depend on pathological items compared with other scales such as the Beck Depression Inventory and does not define clinical depression.
Time Frame
Day 5
Title
Positive and Negative Affect Schedule (PANAS )
Description
Positive and Negative Affect Schedule (PANAS ) is a 20-item scale that assesses both negative and positive affective states. Subjects rate adjectives describing affective states on a scale of 1 to 5 using a specified time period (e.g., now, today, past week etc.). Scores are then added up to generate negative and positive scale scores.
Time Frame
Day 5
Title
The Profile of Mood States (POMS)
Description
The Profile of Mood States (POMS) is a 72-item questionnaire which consists of adjectives commonly used to describe momentary mood states. It has been found to be sensitive to the mood-altering effects of drugs including nicotine. POMS has a 5-point objective rating scale (0=not at all to 5=extremely). There are eight mood states that this scale measures: (1) Anger, (2) Anxiety, (3) Confusion, (4) Depression, (5) Elation, (6) Fatigue, (7) Friendliness and (8) Vigor. POMS will be used during each session to measure effects of atomoxetine or nicotine on mood.
Time Frame
Day 5
Title
Center for Epidemiologic Studies Depression (CES-D) scale
Description
The Center for Epidemiologic Studies Depression (CES-D) scale is a 20-item self-report measure of depressive symptoms. The range of scores is from 0 to 60, with higher scores reflecting increased depressive symptoms 41. The CES-D does not heavily depend on pathological items compared with other scales such as the Beck Depression Inventory and does not define clinical depression.
Time Frame
Day 17
Title
Positive and Negative Affect Schedule (PANAS )
Description
Positive and Negative Affect Schedule (PANAS ) is a 20-item scale that assesses both negative and positive affective states 44. Subjects rate adjectives describing affective states on a scale of 1 to 5 using a specified time period (e.g., now, today, past week etc.). Scores are then added up to generate negative and positive scale scores.
Time Frame
Day 17
Title
The Profile of Mood States (POMS)
Description
The Profile of Mood States (POMS) is a 72-item questionnaire which consists of adjectives commonly used to describe momentary mood states. It has been found to be sensitive to the mood-altering effects of drugs including nicotine. POMS has a 5-point objective rating scale (0=not at all to 5=extremely). There are eight mood states that this scale measures: (1) Anger, (2) Anxiety, (3) Confusion, (4) Depression, (5) Elation, (6) Fatigue, (7) Friendliness and (8) Vigor. POMS will be used during each session to measure effects of atomoxetine or nicotine on mood.
Time Frame
Day 17
Title
Symptom Checklist Form (SCF)
Description
In order to monitor adverse events from the study medications, SCF will be administered before and after each session. SCF is a locally developed symptom checklist that includes possible side effects of study medications with each symptom being scored 1-5.
Time Frame
Day 5
Title
Symptom Checklist Form (SCF)
Description
In order to monitor adverse events from the study medications, SCF will be administered before and after each session. SCF is a locally developed symptom checklist that includes possible side effects of study medications with each symptom being scored 1-5.
Time Frame
Day 17
Title
Nicotine Withdrawal Symptom Checklist (NWSC)
Description
Smokers will be asked to rate several nicotine withdrawal symptoms on a likert scale visual analogue. There are 12 items responses range from 0, "not at all" to 3 "extremely".
Time Frame
Day 5
Title
Nicotine Withdrawal Symptom Checklist (NWSC)
Description
Smokers will be asked to rate several nicotine withdrawal symptoms on a likert scale visual analogue. There are 12 items responses range from 0, "not at all" to 3 "extremely".
Time Frame
Day 17
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female and male smokers, not treatment seeking, aged 18 to 55 years;
history of smoking daily for the past 12 months, at least 5 cigarettes daily;
CO level > 10ppm;
for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Exclusion Criteria:
history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment, coronary artery disease, cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year. We will make an exception for the following Axis I diagnoses: nicotine dependence and alcohol or other drug dependence (i.e., cocaine, opioid) as long as they are not meeting abuse or dependence criteria within the past 3 months for alcohol or drug use;
use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
known allergy to atomoxetine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Arias, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Haven Veterans Affairs
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States
12. IPD Sharing Statement
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Atomoxetine's Effects On Nicotine Response And Stress Response In Smokers
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