Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence

University of Pennsylvania1 site in 1 country62 target enrollmentSeptember 2006

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

September 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Pennsylvania

Eligibility Criteria

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
•Current use or recent discontinuation (within last 14-days) of the following medications:

Arms & Interventions

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).

Intervention: Varenicline

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).

Intervention: Placebo