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Trial record 1 of 1 for:    NCT00944554
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Relapse Prevention With Varenicline (0815)

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. Identifier: NCT00944554
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : June 23, 2017
Last Update Posted : August 3, 2017
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE July 21, 2009
First Posted Date  ICMJE July 23, 2009
Results First Submitted Date  ICMJE April 20, 2017
Results First Posted Date  ICMJE June 23, 2017
Last Update Posted Date August 3, 2017
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
Days to Relapse [ Time Frame: 4 weeks ]
Number of days following the programmed lapse exposure until relapse to smoking occurred
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
Volunteers to relapse and time to relapse [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
Subjective and reinforcing effects of cigarettes [ Time Frame: 1 day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Relapse Prevention With Varenicline
Official Title  ICMJE Relapse Prevention With Varenicline
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Recurrence
  • Smoking Cessation
  • Substance-Related Disorders
Intervention  ICMJE
  • Drug: Varenicline
    Varenicline given twice a day or five weeks.
    Other Name: Varenicline (Chantix®)
  • Drug: Placebo
    Placebo given twice a day or five weeks.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Group given placebo.
    Intervention: Drug: Placebo
  • Experimental: Varenicline
    Experimental group given varenicline dosing.
    Intervention: Drug: Varenicline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2009)
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00944554
Other Study ID Numbers  ICMJE NA_00019900
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Maxine L Stitzer, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date July 2017

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