N-Acetylcysteine for Adolescent Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707951
• Other study ID #: PRO#00080921
• Status: Completed
• Phase: Phase 2
• Start date: February 27, 2019
• Est. completion date: February 26, 2024

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Underage Drinking

Intervention

Drug:
• N-acetylcysteine
N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
• Placebo oral capsule
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in alcohol use	Reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.	8 weeks of treatment