drugset / Trial / NCT02723162

Translational Neuropsychopharmacology Research of Nicotine Addiction

NCT02723162

Phase 2 Completed 67 enrolled Medical University of South Carolina
RandomizedParallel-groupQuadruple-blindHealth-services research

Summary

This study will examine the effects of combining Varenicline (VRN) and N-acetylcysteine (NAC) on neural circuitry function and treating nicotine addiction. Healthy adult nicotine dependent cigarette smokers interested in quitting (n=110) will be randomized to one of four PBO-controlled conditions for 4 weeks: 1) VRN+NAC, 2) VRN+PBO, 3) NAC+PBO or 4) PBO+PBO. Following 1 week of medication, participants will be contingently reinforced for 3 days of smoking abstinence and be scanned using functional magnetic resonance imaging (fMRI) techniques, while nicotine deprived during a resting state and a cue-reactivity (CR) task. Participants will be followed over the next 3 weeks of treatment and clinical variables will be assessed.

Timeline

Start
2016-05-04
Primary completion
2020-03-09
Completion
2020-03-09

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 1200 mg
Subject Varenicline Small molecule 1 mg

Indications