Effects of Chantix on Relapse Prevention for Smoking Cessation

Study Overview
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Brief Summary
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The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.

Detailed Description
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The proposed human experiment will test the validity of a novel paradigm that may provide a method for distinguishing compounds that are likely to have efficacy from those that are not, before they are tested in more costly large-scale clinical trials. Specifically, in a within-subject (cross-over) behavioral pharmacology investigation of 60 smokers, we will test the effects of varenicline versus placebo on smoking behavior in the natural environment following a 3-day period of monitored abstinence and a programmed cigarette lapse. A positive signal for varenicline effects in this study would provide support for the sensitivity of the paradigm. In addition, following completion of all assessments, participants will be followed in a 13-week open-label varenicline smoking cessation trial to determine whether response to varenicline in the laboratory study predicts clinical response in the open-label trial.

Official Title
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Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: Placebo
* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months. Exclusion Criteria: Smoking Behavior Use of chewing tobacco or snuff Current enrollment or plans to enroll in another smoking cessation program in the next 5 months Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months Provide a baseline CO reading < 10 ppm Alcohol/Drug Exclusion Criteria History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants) Current alcohol consumption that exceeds >25 standard drinks/week Medication Exclusion Criteria 1. Current use or recent discontinuation (within last 14-days) of the following medications: Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT) Any form of anti-psychotic medications that includes: antipsychotics, atypical antipsychotics, mood-stabilizers, anti-depressants (tricyclics, SSRI's, MAOI's), anti-panic agents, anti-obsessive agents, anti-anxiety agents, and stimulants (e.g., Provigil, Ritalin). Medication for chronic pain Anti-coagulants Any heart medications Daily medication for asthma Medical Exclusion Criteria Women who are pregnant, planning a pregnancy, or lactating. History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder as identified by the SCID. Serious or unstable disease within the past 6 months (e.g., cancer [except melanoma], heart disease, HIV). History of epilepsy or a seizure disorder. History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP>150 or DBP>90) History of Kidney and/or liver failure (including transplant). Wears a device to aid in hearing (hearing aid, cochlear implant, etc.). Hearing threshold < 40 dB SPL at 1000 Hz. Color blindness. General Exclusion Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician. Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Varenicline<br>Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21). | Drug: Varenicline<br>* Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - End of Treatment 1.0mg twice daily<br>* Other names: Chantix;|
| Placebo Comparator: Placebo<br>Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21). | Drug: Placebo<br>* Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of abstinence following the programmed lapse |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varenicline, Working memory