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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
  Purpose

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 Intervention Phase
Recurrence
Smoking Cessation
Substance-Related Disorders
 Drug: Varenicline
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Relapse Prevention With Varenicline

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Volunteers to relapse and time to relapse [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective and reinforcing effects of cigarettes [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Group given placebo.
 Drug: Placebo
Varenicline and placebo given twice a day or five weeks.
Experimental: Varenicline
Experimental group given varenicline dosing.
 Drug: Varenicline
Varenicline and placebo given twice a day or five weeks.
Other Name: Varenicline (Chantix®)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944554

Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Pfizer
Investigators
Principal Investigator: Maxine L Stitzer, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Maxine L. Stitzer/Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00944554     History of Changes
Other Study ID Numbers: NA_00019900
Study First Received: July 21, 2009
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Relapse
Smoking Cessation
Substance Abuse

Additional relevant MeSH terms:
Recurrence
Smoking
Substance-Related Disorders
Disease Attributes
Pathologic Processes
Habits
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 May 23, 2013