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Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01308736
First received: January 28, 2011
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry 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 ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308736

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

Additional Information:
Participate in Research - Division of Addiction Psychiatry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT01308736     History of Changes
Other Study ID Numbers: WS777117
Study First Received: January 28, 2011
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
tobacco
nicotine
cigarette smoking

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

ClinicalTrials.gov processed this record on June 18, 2013