Relapse Prevention With Varenicline
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Days to Relapse
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Placebo
Group given placebo.
Intervention: Placebo (Drug)
Varenicline
Experimental group given varenicline dosing.
Intervention: Varenicline (Drug)
Outcomes
Primary Outcomes
Days to Relapse
Time Frame: 4 weeks
Number of days following the programmed lapse exposure until relapse to smoking occurred
Secondary Outcomes
No secondary outcomes reported