Conditions: Nicotine Dependence
Keywords: Varenicline, Imaging, fMRI
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 38
Healthy volunteers: yes

Brief summary:
This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.

Detailed description:
Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final eligibility. Following a medication run-up and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan while performing attention, working memory and emotion tasks). After a 14 to 21-day washout period the study procedures will be repeated with placebo (order of study medication counterbalanced). After completion of both study periods, all participants will be offered a 13-week quit smoking program with varenicline.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily intervention 2: Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.

Protocol document: