Effects of Chantix on Relapse Prevention for Smoking Cessation

Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00948649

Enrollment

Registered

2009-07-29

Start date

2006-09-30

Completion date

2007-09-30

Last updated

2010-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence

Keywords

Varenicline, Working memory

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.

Interventions

DRUGPlacebo

Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.

DRUGVarenicline

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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 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

Design outcomes

Primary

Measure	Time frame
Days of abstinence following the programmed lapse	7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026