Overview

Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
Summary
The objective of this proposal is to elucidate effects of bupropion SR + varenicline on smoking-cessation related processes in early abstinence using a human laboratory model. A within-subjects design will be used to assess the additive effects of bupropion and varenicline in 48 treatment seeking smokers [bupropion SR (300 mg/day)+placebo, varenicline (2 mg/day+placebo, and bupropion SR (300 mg/day)+varenicline (2 mg/day)]. Outcomes include withdrawal and craving, cognition, stress tolerance, anxiety, the reinforcing effects of smoking, and smoking topography. Hypotheses: We hypothesize that greatest treatment effects will be observed in the bupropion SR+varenicline group followed by varenicline+placebo and bupropion SR+placebo groups.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
Collaborators:
National Institute on Drug Abuse (NIDA)
Pfizer
Treatments:
Bupropion
Nicotine
Varenicline