Relapse Prevention With Varenicline

Phase 4

Completed

• Conditions: Substance-Related Disorders; Recurrence; Smoking Cessation
• Interventions: Drug: Placebo; Drug: Varenicline

• Registration Number: NCT00944554
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2017-04-20
• Results First Submitted QC: 2017-06-19
• Results First Posted: 2017-06-23
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Group given placebo.
Varenicline	Varenicline	Experimental group given varenicline dosing.

Primary Outcome Measures

Name	Time	Method
Days to Relapse	4 weeks	Number of days following the programmed lapse exposure until relapse to smoking occurred

Trial Locations

Locations (1)

Behavioral Pharmacology Research Unit; 🇺🇸 Baltimore, Maryland, United States