Effects of Chantix on Relapse Prevention for Smoking Cessation

Phase 4

Completed

• Conditions: Nicotine Dependence
• Interventions: Drug: Varenicline; Drug: Placebo

• Registration Number: NCT00948649
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-08
• Study Completion: 2007-09
• Status Verified: 2009-07
• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Last Update Submitted: 2010-08-16
• Last Update Posted: 2010-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

  1. Use of chewing tobacco or snuff
  2. Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
  3. Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
  4. Provide a baseline CO reading < 10 ppm

Alcohol/Drug Exclusion Criteria

1. History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
2. 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:

2. Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT)

3. 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).

4. Medication for chronic pain

5. Anti-coagulants

6. Any heart medications

7. Daily medication for asthma

Medical Exclusion Criteria

1. Women who are pregnant, planning a pregnancy, or lactating.
2. History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder as identified by the SCID.
3. Serious or unstable disease within the past 6 months (e.g., cancer [except melanoma], heart disease, HIV).
4. History of epilepsy or a seizure disorder.
5. 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)
6. History of Kidney and/or liver failure (including transplant).
7. Wears a device to aid in hearing (hearing aid, cochlear implant, etc.).
8. Hearing threshold < 40 dB SPL at 1000 Hz.
9. Color blindness.

General Exclusion

1. Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
2. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
3. Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Varenicline	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).
Placebo	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).

Primary Outcome Measures

Name	Time	Method
Days of abstinence following the programmed lapse	7 days

Trial Locations

Locations (1)

Tobacco Use Research Center, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States