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Mucolytic Agent

N-Acetylcysteine for Cannabis Use Disorder

Phase 2 & 3
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
Age 14 - 21 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly urine cannabinoid tests during 12-week active treatment
Awards & highlights

Study Summary

This trial will test whether N-acetylcysteine can help reduce cannabis use in youth with cannabis use disorder.

Who is the study for?
This trial is for young people aged 14-21 with cannabis use disorder who want treatment. They must understand the study, consent (with guardian consent if under 18), and have used cannabis recently. Females need to follow birth control guidelines. Those with allergies to N-acetylcysteine, severe asthma, seizure disorders, or using certain drugs can't join.Check my eligibility
What is being tested?
The trial tests if N-acetylcysteine helps youth stop using cannabis over a 12-week period compared to a placebo. Participants will also receive weekly counseling and medication management. Success is measured by urine tests showing no cannabis use.See study design
What are the potential side effects?
While not specified here, common side effects of N-acetylcysteine may include nausea, vomiting, rash or fever; however individual experiences may vary.

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 14 and 21 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly urine cannabinoid tests during 12-week active treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly urine cannabinoid tests during 12-week active 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
Proportion of negative urine cannabinoid tests during treatment

Side effects data

From 2022 Phase 2 trial • 44 Patients • NCT04005053
36%
Psychiatric
36%
Gastrointestinal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low-Dose NAC
Placebo
High-Dose NAC

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: N-acetylcysteineExperimental Treatment1 Intervention
N-acetylcysteine 1200 mg twice daily for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cysteine
FDA approved

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
929 Previous Clinical Trials
7,393,625 Total Patients Enrolled
Kevin M Gray, MDPrincipal InvestigatorProfessor of Psychiatry and Behavioral Sciences
7 Previous Clinical Trials
886 Total Patients Enrolled

Media Library

N-acetyl cysteine (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03055377 — Phase 2 & 3
Cannabis Use Disorder Research Study Groups: N-acetylcysteine, Placebo
Cannabis Use Disorder Clinical Trial 2023: N-acetyl cysteine Highlights & Side Effects. Trial Name: NCT03055377 — Phase 2 & 3
N-acetyl cysteine (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03055377 — Phase 2 & 3

Frequently Asked Questions

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

If a patient is outside the age range of this trial, can they still participate?

"As stated in the clinical trial's eligibility requirements, participants must be between 14 and 21 years old."

Answered by AI

How can I become a part of this experiment?

"This study concerning hashish abuse is open to people aged 14-21, with a maximum of 192 participants. To be eligible, potential candidates must meet the age criteria."

Answered by AI

How many people are taking part in this experiment at most?

"Yes, this trial is open and recruiting patients according to the latest information available on clinicaltrials.gov. The study was established on August 3rd, 2017 with the most recent update being on August 1st, 2022. They are looking for a total of 192 participants across one location."

Answered by AI

Are there any available positions for volunteers in this research project?

"That is correct. The clinical trial, as detailed on clinicaltrials.gov, is currently looking for patients to enroll. 8/3/2017 marks the date when the study was originally posted and 8/1/2022 represents the most recent update. So far, 192 people have been recruited from 1 location."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
How old are they?
18 - 65
What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
~25 spots leftby Mar 2025