NCT03238300

Neuroscience-Informed Treatment Development for Adolescent Alcohol Use

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 15 Years – 19 Years
• Healthy volunteers: Accepted

Summary

This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant supplement, on brains of youth (ages 15-19) using magnetic resonance imaging (MRI).

Detailed description

55 adolescents will receive, in a counterbalanced order, a 10-day course of NAC 1200 mg twice daily and a subsequent 10-day course of matched placebo twice daily, separated by 11 days. Urine and blood samples will be collected at baseline and urine samples again before and after each course of medication treatment. Participants will receive a 1- hour MRI scan at baseline and after each treatment trial.

Conditions

• Alcohol Drinking
• Control

Interventions

Type	Name	Description
DRUG	N-Acetylcysteine	N-Acetylcysteine; 600mg capsules by mouth, two pills twice daily (total 2400 mg/day). Participants will undergo MRI (including magnetic resonance imaging and functional MRI during an alcohol cue reactivity task) at baseline, after 10 days of N-Acetylcysteine and after 10 days of placebo.
DRUG	Placebo Oral Capsule	N-acetylcysteine-matched placebo tablet two pills twice daily. Participants will undergo MRI (including magnetic resonance imaging and functional MRI during an alcohol cue reactivity task) at baseline, after 10 days of N-Acetylcysteine and after 10 days of placebo.

Timeline

• Start date: 2017-10-16
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2017-08-03
• Last updated: 2023-06-22
• Results posted: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study