N-Acetylcysteine for Adolescent Alcohol Use Disorder

  • STATUS
    Recruiting
  • End date
    Aug 18, 2023
  • participants needed
    120
  • sponsor
    Medical University of South Carolina
Updated on 28 February 2022
n-acetylcysteine

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.

Details
Condition Alcohol Use Disorder
Treatment N-acetylcysteine, Placebo oral capsule
Clinical Study IdentifierNCT03707951
SponsorMedical University of South Carolina
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is 13-25
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)
Current moderate to heavy drinker by established adolescent criteria
Meet criteria for alcohol use disorder
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

Score >10 on the Clinical Institute Withdrawal Assessment for Alcohol
Allergy or intolerance to N-acetylcysteine
Females who are pregnant, contemplating pregnancy or lactating over the next 6 months
Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)
Current enrollment in treatment for alcohol use disorder or expectation of other treatment during protocol participation
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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