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Mucolytic Agent

N-Acetylcysteine for Adolescent Alcoholism

Phase 2
Waitlist Available
Led By Kevin M Gray, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Subject is 13-25
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks of treatment
Awards & highlights

Study Summary

This trial is testing if N-acetylcysteine can help reduce alcohol use in adolescents with alcohol use disorder.

Who is the study for?
This trial is for adolescents aged 13-25 with alcohol use disorder who drink moderately to heavily. They must understand the study, consent (with guardian consent if under 18), and agree to birth control methods if female. Excluded are those allergic to N-acetylcysteine, pregnant or breastfeeding women, current users of NAC supplements, those in other AUD treatments, or with conditions that could affect safety or results.Check my eligibility
What is being tested?
The trial tests whether N-acetylcysteine can reduce alcohol consumption in adolescents with AUD over an 8-week period compared to a placebo. Participants receive weekly brief alcohol interventions alongside their assigned treatment—either NAC or a placebo capsule.See study design
What are the potential side effects?
While not specified here, common side effects of N-acetylcysteine may include nausea, vomiting, rash and headache. As this is a controlled study any new side effects observed would be documented as part of the research.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use one of the specified birth control methods during the study.
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I am between 13 and 25 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in alcohol use

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: N-acetylcysteineExperimental Treatment1 Intervention
N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally
Group II: PlaceboPlacebo Group1 Intervention
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylcysteine
FDA approved

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,140 Total Patients Enrolled
46 Trials studying Alcoholism
4,985 Patients Enrolled for Alcoholism
Kevin M Gray, MDPrincipal InvestigatorProfessor of Psychiatry and Behavioral Sciences
7 Previous Clinical Trials
958 Total Patients Enrolled

Media Library

N-acetylcysteine (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03707951 — Phase 2
Alcoholism Research Study Groups: N-acetylcysteine, Placebo
Alcoholism Clinical Trial 2023: N-acetylcysteine Highlights & Side Effects. Trial Name: NCT03707951 — Phase 2
N-acetylcysteine (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03707951 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participants to join this experiment?

"Indeed. As per the records on clinicaltrials.gov, this investigational trial is actively seeking participants. The project was first listed on February 27th 2019 and has been revised most recently on August 1st 2022. There are 120 openings at a single medical site for those interested in joining the study."

Answered by AI

To which demographic is this clinical trial open?

"The application process for this trial mandates that applicants must have a history of alcohol consumption and be between the ages 13-25. Approximately 120 participants will gain acceptance into the study."

Answered by AI

What other exploratory studies have used N-acetylcysteine as a factor?

"As of now, there are 38 ongoing studies involving N-acetylcysteine with 7 trials in their final phase. Most of these clinical investigations take place in the state of New york but they span across 44 different locations nationally."

Answered by AI

To what conditions is N-acetylcysteine typically prescribed as a remedy?

"N-acetylcysteine is the recommended treatment for corneal ulceration, in addition to a host of other medical issues such as acute rhinitis, acetaminophen overdose, and various corneal diseases."

Answered by AI

Is geriatric participation welcome in this medical experiment?

"The study is currently enrolling minors aged 13 and above, up to 25 years old."

Answered by AI

How many participants have enrolled in this clinical trial?

"Correct. Records posted on clinicaltrials.gov verify that this medical investigation, which was initially advertised on February 27th 2019, is currently recruiting individuals. 120 participants need to be enrolled from a single site."

Answered by AI

Is N-acetylcysteine a risk-free medication for patients?

"Although no clinical data exists to demonstrate efficacy, N-acetylcysteine still scored a 2 on our scale due to the preliminary evidence of its safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
N-Acetylcysteine for Adolescent Alcohol Use Disorder
Kevin Gray, MD 2019. "N-Acetylcysteine for Adolescent Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03707951.
~20 spots leftby Apr 2025
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