N-Acetylcysteine for Adolescent Alcohol Use Disorder

Adolescence is a critical developmental stage involving marked elevation in alcohol
initiation, progression to AUD, and development of significant, lasting adverse outcomes from
use. Effective treatments must be developed for AUD in this especially vulnerable age range.
The identification of a well-tolerated, effective pharmacological treatment would represent a
significant advance and could yield tremendous public health impact. The proposed trial will
provide critical data to evaluate NAC as a highly promising pharmacotherapy for adolescent
AUD, and regardless of NAC versus placebo outcomes will provide key methodological guidance
for future randomized controlled trials of pharmacotherapies for adolescent AUD. Randomized
participants will be provided and instructed to take their assigned medication at 1200 mg
twice daily, in approximately twelve-hour intervals.

Inclusion Criteria:

1. Subject is 13-19

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 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