Clinical trial NCT03707951: N-Acetylcysteine for Adolescent Alcohol Use Disorder
Official title: A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: alcohol
youth
adolescent
pharmacotherapy
medication
N-acetylcysteine
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 126
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 parallel group allocation randomized placebo controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8)
timeFrame: Final 4 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Professor of Psychiatry and Behavioral Sciences
name: Kevin M Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: