At a glance
ClinicalIndex Comparison Record- ✓Age 18–55 years
- ✓Smoke ≥10 cigarettes/day for a minimum of two years
- ✓Expired carbon monoxide concentration ≥10 ppm to confirm inhalation
- ✓Interest in quitting smoking or contemplating a quit attempt in the next 6 months
- ✕Past head injury or primary neurological disorder associated with MRI abnormalities (dementia, MCI, brain tumors, epilepsy, Parkinson's disease, demyelinating diseases)
- ✕Any contraindication to MRI
- ✕Positive urine drug screen for illicit substances (marijuana, cocaine)
- ✕Current or past psychosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Translational Neuropsychopharmacology Research of Nicotine Addiction
In Brief
A Phase 2 clinical trial evaluating Varenicline (VRN), N-Acetylcysteine (NAC), and 1 other intervention for Nicotine Dependence, Cigarettes. Completed, enrolled 67 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
Matched placebo