Status:
COMPLETED
Relapse Prevention With Varenicline
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Pfizer
Conditions:
Recurrence
Smoking Cessation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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. Th...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00944554
Start Date
October 1 2008
End Date
May 1 2011
Last Update
August 3 2017
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224