Effects of Chantix on Relapse Prevention for Smoking Cessation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nicotine Dependence |
Drug: Placebo Drug: Varenicline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Screening |
| Official Title: | Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence |
- Days of abstinence following the programmed lapse [ Time Frame: 7 days ] [ Designated as safety issue: No ]
| Enrollment: | 62 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Varenicline
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
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
Other Name: Chantix
|
|
Placebo Comparator: Placebo
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
Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Pennsylvania | |
| Tobacco Use Research Center, University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Caryn Lerman, Ph.D. | University of Pennsylvania |
More Information
Publications:
| Responsible Party: | Caryn Lerman, Ph.D., University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00948649 History of Changes |
| Other Study ID Numbers: | 805394 |
| Study First Received: | July 28, 2009 |
| Last Updated: | August 16, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pennsylvania:
|
Varenicline, Working memory |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Varenicline Nicotinic Agonists Cholinergic Agonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013