Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
Overview
- Phase
- Not Applicable
- Intervention
- Varenicline
- Conditions
- Tobacco Use Disorder
- Sponsor
- Rutgers, The State University of New Jersey
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Cigarette Reduction
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.
Investigators
Marc L. Steinberg, Ph.D.
Associate Professor
Rutgers University
Eligibility Criteria
Inclusion Criteria
- •Must smoke at least 10 cigarettes per day for past 6-months
- •Must have a working cellular or land-line phone
Exclusion Criteria
- •Must not be thinking of quitting in the next 30 days, but be interested in cutting down- Must not regularly (more than 1x/month) use tobacco products other than cigarettes
- •Must not be currently receiving tobacco dependence treatment counseling
- •Must not currently be taking varenicline, bupropion, nortriptyline, or any nicotine preparations (gum, lozenge, patch, spray, inhaler)
- •Must not have positive screen on SCID-I/NP Psychotic Screen
- •Must have no contraindications to using varenicline, including pregnancy, as measured by Medical History Form
Arms & Interventions
varenicline
Intervention: Varenicline
placebo pill
Intervention: Placebo pill
Outcomes
Primary Outcomes
Cigarette Reduction
Time Frame: At 6-month follow-up
50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.