Translational Neuropsychopharmacology Research of Nicotine Addiction

• Status: Completed
• Trial end date: 2020-03-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Acetylcysteine; N-monoacetylcystine; Nicotine; Varenicline

Criteria

Inclusion Criteria:

1. Age 18 - 55

2. Right Handed

3. English fluency

4. 20/20 vision with corrective lenses.

5. Smoke ≥ 10 cigarettes/day for a minimum of two years and have an expired carbon monoxide (CO) concentration of ≥ 10 ppm (to confirm inhalation).

6. Interest in quitting smoking or contemplating a quit attempt in the next 6 months

7. If female, agreement to use birth control

Exclusion Criteria:

1. Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases

2. Any physical or intellectual disability affecting completion of assessments

3. Any contraindication to MRI

4. Positive urine drug screen for illicit substances (such as marijuana or cocaine).

5. Current or past psychosis

6. Electroconvulsive therapy in last 6 months

7. Use of antidepressant medications or other psychotropic medications in the last month.

8. Positive urine pregnancy test or current breast feeding status