Relapse Prevention With Varenicline
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrence; Smoking Cessation; Substance-Related Disorders
Intervention: Varenicline (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Maxine L Stitzer, PhD, Principal Investigator, Affiliation: Johns Hopkins University
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.
Clinical Details
Official title: Relapse Prevention With Varenicline
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
Primary outcome: Volunteers to relapse and time to relapse
Secondary outcome: Subjective and reinforcing effects of cigarettes
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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)
Locations and Contacts
Behavioral Pharmacology Research Unit, Baltimore, Maryland 21224, United States
Additional Information
Starting date: October 2008
Last updated: May 31, 2012
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