Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit|
- Cigarette Reduction [ Time Frame: At 6-month follow-up ] [ Designated as safety issue: No ]50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.
|Study Start Date:||January 2011|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: varenicline||
Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
|Placebo Comparator: placebo pill||
Drug: Placebo pill
Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308736
|United States, New Jersey|
|Division of Addiction Psychiatry|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Marc L Steinberg, Ph.D.||University of Medicine and Dentistry of New Jersey|