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Relapse Prevention With Varenicline (0815)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944554
First Posted: July 23, 2009
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Johns Hopkins University
July 21, 2009
July 23, 2009
April 20, 2017
June 23, 2017
August 3, 2017
October 2008
May 2011   (Final data collection date for primary outcome measure)
Days to Relapse [ Time Frame: 4 weeks ]
Number of days following the programmed lapse exposure until relapse to smoking occurred
Volunteers to relapse and time to relapse [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT00944554 on ClinicalTrials.gov Archive Site
Not Provided
Subjective and reinforcing effects of cigarettes [ Time Frame: 1 day ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
  • Recurrence
  • Smoking Cessation
  • Substance-Related Disorders
  • Drug: Varenicline
    Varenicline given twice a day or five weeks.
    Other Name: Varenicline (Chantix®)
  • Drug: Placebo
    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
104
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 Diagnostic and Statistical Manual (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 Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00944554
NA_00019900
Yes
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Pfizer
Principal Investigator: Maxine L Stitzer, PhD Johns Hopkins University
Johns Hopkins University
July 2017

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