N-Acetylcysteine for Adolescent Alcohol Use Disorder

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 8-week randomized, placebo-controlled trial testing the effects of N-acetylcysteine (NAC), on a platform of weekly evidence-based brief alcohol intervention for 120 adolescents with alcohol use disorder (AUD). The primary efficacy endpoint is reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Subject is 13-25

2. Must be able to understand the study and provide written informed consent (for participants under 18 years old, a parent/legal guardian must be able to provide consent and the participant must be able to provide assent).

3. Current moderate to heavy drinker by established adolescent criteria

4. Meet criteria for alcohol use disorder

5. Females must agree to use appropriate birth control methods during study participation: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring

Exclusion Criteria:

1. Score >10 on the Clinical Institute Withdrawal Assessment for Alcohol

2. Allergy or intolerance to N-acetylcysteine

3. Females who are pregnant, contemplating pregnancy or lactating over the next 6 months

4. Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)

5. Current enrollment in treatment for alcohol use disorder or expectation of other treatment during protocol participation

6. Any other medical or psychiatric condition or other significant concern that in the Investigator's opinion would impact participant safety or compliance with study instructions, or potentially cofound the interpretation of findings