Overview

Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborator:
Pfizer
Treatments:
Varenicline
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