N/A
N=63
Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01308736 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Cigarette Reduction — 10; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Varenicline (Drug); Placebo pill (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarette Reduction |
10; 11 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01308736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.