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Relapse Prevention With Varenicline (0815)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00944554
First received: July 21, 2009
Last updated: May 31, 2012
Last verified: July 2009
History of Changes

July 21, 2009
May 31, 2012
October 2008
May 2011   (final data collection date for primary outcome measure)
Volunteers to relapse and time to relapse [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00944554 on ClinicalTrials.gov Archive Site
Subjective and reinforcing effects of cigarettes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Relapse Prevention With Varenicline
Relapse Prevention With Varenicline

This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.

In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
  • Recurrence
  • Smoking Cessation
  • Substance-Related Disorders
  • Drug: Varenicline
    Varenicline and placebo given twice a day or five weeks.
    Other Name: Varenicline (Chantix®)
  • Drug: Placebo
    Varenicline and placebo given twice a day or five weeks.
  • Placebo Comparator: Placebo
    Group given placebo.
    Intervention: Drug: Placebo
  • Experimental: Varenicline
    Experimental group given varenicline dosing.
    Intervention: Drug: Varenicline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-75 years old
  • Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake
  • Contemplating a smoking cessation attempt in the near future
  • Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion
  • Able to give informed consent

Exclusion Criteria:

  • Currently meets DSM-IV criteria for depression, bi-polar disorder, or schizophrenia
  • History of attempted suicide or expresses any current suicidal ideation
  • Pregnant, breast feeding, or planning to become pregnant within the next 3 months
  • Reports desire for immediate treatment of tobacco/nicotine dependence
  • Severe impairment of renal function indicated by GFR less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00944554
NA_00019900
Yes
Maxine L. Stitzer/Professor, Johns Hopkins University
Johns Hopkins University
Pfizer
Principal Investigator: Maxine L Stitzer, PhD Johns Hopkins University
Johns Hopkins University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP