Back to results

N-Acetylcysteine for Adolescent Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

N-acetylcysteine

Placebo oral capsule

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring alcohol, youth, adolescent, pharmacotherapy, medication, N-acetylcysteine

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-acetylcysteine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reduction in alcohol use

Reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.

Secondary Outcome Measures

Full Information

NCT ID

NCT03707951

First Posted

October 12, 2018

Last Updated

July 31, 2023

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT03707951

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 27, 2019 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

alcohol, youth, adolescent, pharmacotherapy, medication, N-acetylcysteine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

1:1 parallel group allocation randomized placebo controlled trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double-blind placebo-controlled pharmacotherapy trial

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

N-acetylcysteine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

N-acetylcysteine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Intervention Description

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

Primary Outcome Measure Information:

Title

Reduction in alcohol use

Description

Reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.

Time Frame

8 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cori Herring, BS

Phone

843-792-8207

herrinco@musc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kevin M Gray, MD

Phone

843-792-6330

graykm@musc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin M Gray, MD

Organizational Affiliation

Professor of Psychiatry and Behavioral Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cori Herring, BS

Phone

843-792-8207

herrinco@musc.edu

First Name & Middle Initial & Last Name & Degree

Kevin Gray, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

N-Acetylcysteine for Adolescent Alcohol Use Disorder

We'll reach out to this number within 24 hrs