Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: Placebo pill; Drug: Varenicline

• Registration Number: NCT01308736
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-28
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-05-18
• Results First Submitted QC: 2015-07-22
• Results First Posted: 2015-07-23
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo pill	Placebo pill	-
varenicline	Varenicline	-

Primary Outcome Measures

Name	Time	Method
Cigarette Reduction	At 6-month follow-up	50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.

Trial Locations

Locations (1)

Division of Addiction Psychiatry; 🇺🇸 New Brunswick, New Jersey, United States