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Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

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ClinicalTrials.gov Identifier: NCT01308736
Recruitment Status : Completed
First Posted : March 4, 2011
Results First Posted : July 23, 2015
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Marc L. Steinberg, Ph.D., Rutgers University

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Varenicline Drug: Placebo pill Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
Study Start Date : January 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308736


Locations
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
Pfizer
Investigators
Principal Investigator: Marc L Steinberg, Ph.D. University of Medicine and Dentistry of New Jersey

Responsible Party: Marc L. Steinberg, Ph.D., Associate Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT01308736     History of Changes
Other Study ID Numbers: WS777117
First Posted: March 4, 2011    Key Record Dates
Results First Posted: July 23, 2015
Last Update Posted: July 17, 2017
Last Verified: July 2017

Keywords provided by Marc L. Steinberg, Ph.D., Rutgers University:
tobacco
nicotine
cigarette smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs