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.

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Cigarette Smoking Mental Disorders Smoking Substance-Related Disorders Tobacco Smoking Tobacco Use

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Addiction Psychiatry

New Brunswick, New Jersey, 08901, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

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 pill

Drug

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.

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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

Pfizer

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Mar 4, 2011
Registry last updated: Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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