N-Acetylcysteine for Adolescent Alcohol Use Disorder

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT03707951

Collaborator

(none)

120

Enrollment

Location

Arms

66.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Drug: N-acetylcysteine Drug: Placebo oral capsule	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 parallel group allocation randomized placebo controlled trial1:1 parallel group allocation randomized placebo controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double-blind placebo-controlled pharmacotherapy trial

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 27, 2019

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: N-acetylcysteine N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally	Drug: N-acetylcysteine N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
Placebo Comparator: Placebo Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally	Drug: Placebo oral capsule Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)

Arm

Intervention/Treatment

Experimental: N-acetylcysteine

N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally

Drug: N-acetylcysteine

N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)

Placebo Comparator: Placebo

Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally

Drug: Placebo oral capsule

Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)

Outcome Measures

Primary Outcome Measures

Reduction in alcohol use [8 weeks of treatment]
Reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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