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Effects of ABT-089 on Smoking Abstinence Symptoms and Reward

Primary Purpose

Nicotine Addiction

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-089
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Addiction focused on measuring Smoking, Tobacco

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria.

Eligible subjects will be:

  1. Male and female smokers who are between 18 and 65 years of age and self-report smoking at least 10 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
  2. Healthy as determined by the Study Physician, based on relevant medical history, physical examination (including vitals), and basic screening tests (CBC, CHEM7, AST/ALT).
  3. Smokers who wish to quit smoking in the next 2-6 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior. Using a scale from 0 to 100 (100, being extremely interested), subjects must rate their interest in quitting smoking within the next 6 months greater than 50.
  4. Able to communicate fluently in English (speaking, writing, and reading).
  5. Plan to live in the area for the next 2 months.
  6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

Exclusion Criteria.

Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study:

  1. Smoking behavior.

    1. Current enrollment or firm plans to quit smoking and/or enroll in a smoking cessation program within the next 2 months.
    2. Current and/or anticipated use of any nicotine substitutes and/or smoking cessation treatments/medications within the next 2 months.
    3. Provide a Carbon Monoxide (CO) reading less than 11 parts per million (ppm) at Intake.
    4. Provide a CO reading of 10 ppm or greater at either Testing Visit (Days 6 and 37). If the CO reading is greater than or equal to 10 ppm, but there is a 50% reduction from the CO reading collected at the Baseline/Period 1 Medication Pick-Up Visit, this will be sufficient and the subject may continue as scheduled.
    5. Self-report smoking during the mandatory abstinence period at either Testing Visit (Days 6 and 37).
    6. Regular use of chewing tobacco or snus.
  2. Alcohol/Drugs.

    1. History of substance abuse in the past 6 months and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants). Subjects reporting a history of substance abuse must be in remission at least 6 months or greater.
    2. Current alcohol consumption that exceeds 25 standard drinks/week.
    3. Provide a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 at Intake, Baseline/Period 1 Medication Pick-Up, or Testing Visits (Days 6 and 37).
    4. A positive urine drug screen for cocaine, PCP, amphetamines, methamphetamines, tricyclic antidepressants, opiates, methadone, benzodiazepines, and/or barbiturates at Intake, Baseline/Period 1 Medication Pick-Up, Period 2 Medication Pick-Up, and Observation Visits on Days 10 and 41.
  3. Medical.

    1. Women who are pregnant, planning a pregnancy, and/or breast feeding. All female subjects will undergo a urine pregnancy test at Intake, after which only females determined to be of childbearing potential will complete a urine pregnancy test at Baseline/Period 1 Medication Pick-Up, Period 2 Medication Pick-Up, and Observation Visits on Days 10 and 41. By signing the combined consent and HIPAA form, women of childbearing potential agree to use an approved method of contraception during the study.
    2. Men who do not agree to use an approved method of contraception during the study. Men who are sexually active must be surgically sterile (vasectomy) or using a barrier method (condom) of birth control for the duration of the study. By signing the combined consent and HIPAA form, men agree to use an approved method of contraception.
    3. Current treatment of cancer or diagnosed with cancer (except basal cell carcinoma) in the past 6 months.
    4. Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing neurocognitive task performance.
    5. Color blindness.
    6. History of brain injury.
    7. History of epilepsy or a seizure disorder.
    8. Low or borderline intellectual functioning - determined by receiving a score of less than 90 on the Shipley Institute of Living Scale (SILS, administered at Intake), which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated IQ Test.
    9. Serious or unstable disease within the past 6 months (i.e., heart disease, liver/kidney failure).
    10. Recent history (last 6 months) of abnormal heart rhythms, tachycardia, and/or cardiovascular disease (stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case-by-case basis by the Study Physician.
    11. Clinically significant abnormalities determined by physical examination and collection of vital signs at Intake. Abnormalities will be assessed by the Study Physician and eligibility will be determined on a case-by-case basis.
    12. Uncontrolled hypertension (Systolic Blood Pressure [SBP] greater than or equal to 160 mmHg and/or Diastolic Blood Pressure [DBP] greater than or equal to 100 mmHg).
    13. Heart rate/pulse greater than or equal to 110 beats per minute (bpm).
    14. Clinically significant abnormalities in clinical chemistry (CBC, CHEM7, and AST/ALT). Results greater than 20% outside of normal range will be evaluated for clinical significance by the Study Physician and eligibility will be determined on a case-by-case basis.
    15. Inability to provide an assessable blood sample for basic screening tests (CBC, CHEM7, and AST/ALT) at Intake.
  4. Psychiatric.

    As determined by self-report, the Mini International Neuropsychiatric Interview (MINI), and/or Columbia-Suicide Severity Rating Scale (C-SSRS):

    1. Any suicide risk score on the MINI.
    2. Current (past month) suicidal ideation or lifetime suicidal behavior on the C-SSRS.
    3. Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
    4. Current diagnosis of major depression and/or recurrent major depression. Persons with a history of a single episode of major depression, in remission for 6 months or longer, are eligible provided they are not excluded based on medications (see Medication Exclusion Criteria).
    5. Current or past hypomanic/manic episode.
    6. History or current diagnosis of posttraumatic stress disorder (PTSD).
    7. Prior or current diagnosis of attention deficit hyperactivity disorder (ADHD).
  5. Medication.

    1. Current use or recent discontinuation (within the last 14 days at the time of Intake) of:

      • Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix).
      • Anti-anxiety or panic disorder medications.
      • Anti-psychotic medications.
      • Medications used to treat depression (e.g., Wellbutrin, MAOIs, SSRIS, tricyclic antidepressants).
      • Prescription stimulants (e.g., Provigil, Ritalin, Adderall).
      • Systemic corticosteroids.
    2. Current use of:

      • Nicotine replacement therapy (NRT).
    3. Daily use of:

      • Opiate-containing medications for chronic pain.
      • Inhaled corticosteroids.

Sites / Locations

  • Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ABT-089

Placebo

Arm Description

During both 10-day study medication periods (Days 1-10 & Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order. Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during the 10-day medication period. During study medication period 2, these subjects will take four capsules of the matched placebo capsules.

These are matched placebo capsules manufactured by the study drug supplier. During both 10-day study medication periods (Days 1-10 & Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order. Those randomized to matched placebo during study medication period 1 will take four capsules daily during the 10-day medication period. During study medication period 2, these subjects will take four 10mg capsules (40mg daily) of the active ABT-089 capsules.

Outcomes

Primary Outcome Measures

Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)

Secondary Outcome Measures

Effects of ABT-089 on Mood
PANAS: The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, was used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. Scores for the 10 items on each subscale were summed to create summary scores (range: 10-50); higher scores indicate greater intensity of mood (i.e., more positive or more negative affect). Higher ratings of positive affect and lower ratings of negative affect are considered better outcomes.
Effects of ABT-089 on Withdrawal Symptoms
MNWS: The Minnesota Nicotine Withdrawal Scale - Revised version captures the current state of nicotine withdrawal. The scale assesses 15 items of nicotine withdrawal (including 7 DSM-IV items) such as: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, difficulty concentrating, restlessness, and increased appetite/weight gain. Subjects will rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe. A "withdrawal discomfort score" was calculated as the sum of the first 9 items (possible range: 0-36) and is a well-validated measure of nicotine withdrawal; a higher score indicates more severe withdrawal.
Effects of ABT-089 on Smoking Urges/Craving
QSU-B: The 10-item brief QSU (QSU-B) questionnaire was used to assess smoking urges. Each item is rated on a 7-point scale (1 = strongly disagree, 7 = strongly agree). A total score is calculated as the sum of the individual items (range: 10-70). Higher scores indicate more severe urges to smoke.
Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms
ADHD symptoms: The 27-item BAARS-IV scale was used to assess current attention-deficit and hyperactive symptoms. Participant rated the intensity of their symptoms using the following scale: 1= never or rarely, 2 = sometimes, 3 = often, or 4 = very often. A total score was calculated as the sum of the individual items (range: 27-108). Higher scores indicate more frequent ADHD symptoms.
Effects of ABT-089 on Cigarette Ratings
Cigarette evaluation scale: The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations. Items are rated on a scale from 1 ("Not at all") to 7 ("Extremely); a summary score is calculated as the mean of all responses (range: 1-7). Higher scores indicate stronger subjective effects of smoking.
Effects of ABT-089 on Days of Biochemically-confirmed Abstinence
Daily smoking rate will be assessed at each in-person visit using the Timeline Follow-Back assessment. Abstinence will be confirmed by exhaled carbon monoxide levels during a ~4-day monitored abstinence phase within each period.

Full Information

First Posted
December 19, 2012
Last Updated
October 23, 2014
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01756053
Brief Title
Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
Official Title
A Pilot Feasibility Study of the Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Trial discontinued based on the results of an interim futility analysis.
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089 (an experimental medication not approved by the FDA) when administered as 40mg oral once daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive deficits, smoking withdrawal, smoking urges, smoking reward, and a brief, monitored quit attempt (~4 days). The key cognitive domains include: working memory, sustained attention, and response inhibition.
Detailed Description
This is a single-site, phase IIa, double-blind, within-subject, cross-over, human laboratory study. Subjects will be healthy, treatment-seeking female and male adult smokers, ages 18 to 65 years old. Subjects deemed eligible for participation after an Intake Visit (~Day -7) will complete baseline assessments and receive period 1 medication (ABT-089 or placebo) at the Baseline Visit (Day 0). Subjects will take 40mg of ABT-089 or placebo, based on random assignment, every day for two identical 10-day study treatment periods. Subjects will begin period 1 study medication on Day 1. On Days 3 and 5, subjects will complete in-clinic medication run-up and monitoring assessments. On Day 5, subjects will begin a ~24-hour period of mandatory abstinence from smoking. Day 6 is conducted in two parts. Part 1 will consist of confirmation of smoking abstinence, testing for abstinence-induced cognitive deficits and the collection of subjective assessments. Part 2 will begin with a programmed smoking lapse, after which the subjective rewarding value of the programmed lapse cigarette will be assessed. Before leaving the clinic on Day 6, subjects will receive brief cessation counseling and be instructed to try to remain abstinent from 10pm that evening until after the final Observation Visit on Day 10. During the ~4-day monitored abstinence/observation phase, subjects will complete in-clinic observation visits (subjective assessments, medication adherence, etc.) on Days 7, 8, and 10. After a ~3-week medication washout period and Period 2 Medication Pick-up Visit on ~Day 31, subjects will begin study medication (either ABT-089 or placebo; but will always be the opposite of the assigned study medication in period 1) and participate in period 2 of the study following the same procedures as period 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Addiction
Keywords
Smoking, Tobacco

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-089
Arm Type
Active Comparator
Arm Description
During both 10-day study medication periods (Days 1-10 & Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order. Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during the 10-day medication period. During study medication period 2, these subjects will take four capsules of the matched placebo capsules.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
These are matched placebo capsules manufactured by the study drug supplier. During both 10-day study medication periods (Days 1-10 & Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order. Those randomized to matched placebo during study medication period 1 will take four capsules daily during the 10-day medication period. During study medication period 2, these subjects will take four 10mg capsules (40mg daily) of the active ABT-089 capsules.
Intervention Type
Drug
Intervention Name(s)
ABT-089
Other Intervention Name(s)
Pozanicline
Intervention Description
Selective neuronal nicotinic receptor agonist.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo capsules supplied by study drug supplier.
Primary Outcome Measure Information:
Title
Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)
Description
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
Time Frame
Baseline (Day 0) and Test Day (Days 6 & 37)
Title
Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)
Description
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
Time Frame
Baseline (Day 0) and Test Day (Days 6 & 37)
Secondary Outcome Measure Information:
Title
Effects of ABT-089 on Mood
Description
PANAS: The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, was used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. Scores for the 10 items on each subscale were summed to create summary scores (range: 10-50); higher scores indicate greater intensity of mood (i.e., more positive or more negative affect). Higher ratings of positive affect and lower ratings of negative affect are considered better outcomes.
Time Frame
Days 6 and 37
Title
Effects of ABT-089 on Withdrawal Symptoms
Description
MNWS: The Minnesota Nicotine Withdrawal Scale - Revised version captures the current state of nicotine withdrawal. The scale assesses 15 items of nicotine withdrawal (including 7 DSM-IV items) such as: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, difficulty concentrating, restlessness, and increased appetite/weight gain. Subjects will rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe. A "withdrawal discomfort score" was calculated as the sum of the first 9 items (possible range: 0-36) and is a well-validated measure of nicotine withdrawal; a higher score indicates more severe withdrawal.
Time Frame
Days 6 and 37
Title
Effects of ABT-089 on Smoking Urges/Craving
Description
QSU-B: The 10-item brief QSU (QSU-B) questionnaire was used to assess smoking urges. Each item is rated on a 7-point scale (1 = strongly disagree, 7 = strongly agree). A total score is calculated as the sum of the individual items (range: 10-70). Higher scores indicate more severe urges to smoke.
Time Frame
Days 6 and 37
Title
Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms
Description
ADHD symptoms: The 27-item BAARS-IV scale was used to assess current attention-deficit and hyperactive symptoms. Participant rated the intensity of their symptoms using the following scale: 1= never or rarely, 2 = sometimes, 3 = often, or 4 = very often. A total score was calculated as the sum of the individual items (range: 27-108). Higher scores indicate more frequent ADHD symptoms.
Time Frame
Days 6 and 37
Title
Effects of ABT-089 on Cigarette Ratings
Description
Cigarette evaluation scale: The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations. Items are rated on a scale from 1 ("Not at all") to 7 ("Extremely); a summary score is calculated as the mean of all responses (range: 1-7). Higher scores indicate stronger subjective effects of smoking.
Time Frame
Days 6 and 37
Title
Effects of ABT-089 on Days of Biochemically-confirmed Abstinence
Description
Daily smoking rate will be assessed at each in-person visit using the Timeline Follow-Back assessment. Abstinence will be confirmed by exhaled carbon monoxide levels during a ~4-day monitored abstinence phase within each period.
Time Frame
Days 7, 8, 9, 10, 38, 39, 40, & 41

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria. Eligible subjects will be: Male and female smokers who are between 18 and 65 years of age and self-report smoking at least 10 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months. Healthy as determined by the Study Physician, based on relevant medical history, physical examination (including vitals), and basic screening tests (CBC, CHEM7, AST/ALT). Smokers who wish to quit smoking in the next 2-6 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior. Using a scale from 0 to 100 (100, being extremely interested), subjects must rate their interest in quitting smoking within the next 6 months greater than 50. Able to communicate fluently in English (speaking, writing, and reading). Plan to live in the area for the next 2 months. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form. Exclusion Criteria. Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study: Smoking behavior. Current enrollment or firm plans to quit smoking and/or enroll in a smoking cessation program within the next 2 months. Current and/or anticipated use of any nicotine substitutes and/or smoking cessation treatments/medications within the next 2 months. Provide a Carbon Monoxide (CO) reading less than 11 parts per million (ppm) at Intake. Provide a CO reading of 10 ppm or greater at either Testing Visit (Days 6 and 37). If the CO reading is greater than or equal to 10 ppm, but there is a 50% reduction from the CO reading collected at the Baseline/Period 1 Medication Pick-Up Visit, this will be sufficient and the subject may continue as scheduled. Self-report smoking during the mandatory abstinence period at either Testing Visit (Days 6 and 37). Regular use of chewing tobacco or snus. Alcohol/Drugs. History of substance abuse in the past 6 months and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants). Subjects reporting a history of substance abuse must be in remission at least 6 months or greater. Current alcohol consumption that exceeds 25 standard drinks/week. Provide a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 at Intake, Baseline/Period 1 Medication Pick-Up, or Testing Visits (Days 6 and 37). A positive urine drug screen for cocaine, PCP, amphetamines, methamphetamines, tricyclic antidepressants, opiates, methadone, benzodiazepines, and/or barbiturates at Intake, Baseline/Period 1 Medication Pick-Up, Period 2 Medication Pick-Up, and Observation Visits on Days 10 and 41. Medical. Women who are pregnant, planning a pregnancy, and/or breast feeding. All female subjects will undergo a urine pregnancy test at Intake, after which only females determined to be of childbearing potential will complete a urine pregnancy test at Baseline/Period 1 Medication Pick-Up, Period 2 Medication Pick-Up, and Observation Visits on Days 10 and 41. By signing the combined consent and HIPAA form, women of childbearing potential agree to use an approved method of contraception during the study. Men who do not agree to use an approved method of contraception during the study. Men who are sexually active must be surgically sterile (vasectomy) or using a barrier method (condom) of birth control for the duration of the study. By signing the combined consent and HIPAA form, men agree to use an approved method of contraception. Current treatment of cancer or diagnosed with cancer (except basal cell carcinoma) in the past 6 months. Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing neurocognitive task performance. Color blindness. History of brain injury. History of epilepsy or a seizure disorder. Low or borderline intellectual functioning - determined by receiving a score of less than 90 on the Shipley Institute of Living Scale (SILS, administered at Intake), which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated IQ Test. Serious or unstable disease within the past 6 months (i.e., heart disease, liver/kidney failure). Recent history (last 6 months) of abnormal heart rhythms, tachycardia, and/or cardiovascular disease (stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case-by-case basis by the Study Physician. Clinically significant abnormalities determined by physical examination and collection of vital signs at Intake. Abnormalities will be assessed by the Study Physician and eligibility will be determined on a case-by-case basis. Uncontrolled hypertension (Systolic Blood Pressure [SBP] greater than or equal to 160 mmHg and/or Diastolic Blood Pressure [DBP] greater than or equal to 100 mmHg). Heart rate/pulse greater than or equal to 110 beats per minute (bpm). Clinically significant abnormalities in clinical chemistry (CBC, CHEM7, and AST/ALT). Results greater than 20% outside of normal range will be evaluated for clinical significance by the Study Physician and eligibility will be determined on a case-by-case basis. Inability to provide an assessable blood sample for basic screening tests (CBC, CHEM7, and AST/ALT) at Intake. Psychiatric. As determined by self-report, the Mini International Neuropsychiatric Interview (MINI), and/or Columbia-Suicide Severity Rating Scale (C-SSRS): Any suicide risk score on the MINI. Current (past month) suicidal ideation or lifetime suicidal behavior on the C-SSRS. Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia. Current diagnosis of major depression and/or recurrent major depression. Persons with a history of a single episode of major depression, in remission for 6 months or longer, are eligible provided they are not excluded based on medications (see Medication Exclusion Criteria). Current or past hypomanic/manic episode. History or current diagnosis of posttraumatic stress disorder (PTSD). Prior or current diagnosis of attention deficit hyperactivity disorder (ADHD). Medication. Current use or recent discontinuation (within the last 14 days at the time of Intake) of: Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix). Anti-anxiety or panic disorder medications. Anti-psychotic medications. Medications used to treat depression (e.g., Wellbutrin, MAOIs, SSRIS, tricyclic antidepressants). Prescription stimulants (e.g., Provigil, Ritalin, Adderall). Systemic corticosteroids. Current use of: Nicotine replacement therapy (NRT). Daily use of: Opiate-containing medications for chronic pain. Inhaled corticosteroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caryn Lerman, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.med.upenn.edu/cirna/
Description
CIRNA Center homepage

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Effects of ABT-089 on Smoking Abstinence Symptoms and Reward

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