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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrence Smoking Cessation Substance-Related Disorders Drug: Varenicline Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Relapse Prevention With Varenicline
Study Start Date : October 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Group given placebo.
 Drug: Placebo
Placebo given twice a day or five weeks.
Experimental: Varenicline
Experimental group given varenicline dosing.
 Drug: Varenicline
Varenicline given twice a day or five weeks.
Other Name: Varenicline (Chantix®)


Outcome Measures
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Primary Outcome Measures :
  1. Days to Relapse [ Time Frame: 4 weeks ]
    Number of days following the programmed lapse exposure until relapse to smoking occurred


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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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): NCT00944554


Locations
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United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Pfizer
Investigators
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Principal Investigator: Maxine L Stitzer, PhD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00944554    
Other Study ID Numbers: NA_00019900
First Posted: July 23, 2009    Key Record Dates
Results First Posted: June 23, 2017
Last Update Posted: August 3, 2017
Last Verified: July 2017
Keywords provided by Johns Hopkins University:
Relapse
Smoking Cessation
Substance Abuse
Additional relevant MeSH terms:
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Recurrence
Substance-Related Disorders
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Varenicline
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs