Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

This study has been completed.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey Identifier:
First received: January 28, 2011
Last updated: March 13, 2014
Last verified: March 2014

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.

Condition Intervention
Tobacco Use Disorder
Drug: Varenicline
Drug: Placebo pill

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Tobacco Use as measured by cigarettes per day with self-reported abstinence verified by carbon monoxide reading of less than 10ppm [ Time Frame: Over 6 months ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: January 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline Drug: 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.


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01308736

United States, New Jersey
Division of Addiction Psychiatry
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Principal Investigator: Marc L Steinberg, Ph.D. University of Medicine and Dentistry of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey Identifier: NCT01308736     History of Changes
Other Study ID Numbers: WS777117
Study First Received: January 28, 2011
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
cigarette smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs processed this record on April 22, 2014