N-Acetylcysteine for Youth Cannabis Use Disorder

NCT03055377 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: Pro00054499
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12-week randomized, placebo-controlled trial of N-acetylcysteine for cannabis use disorder (CUD) in youth (N=192). Participants will be randomized to double-blind NAC or PBO, yielding two equally-allocated treatment groups. All participants will receive brief weekly cannabis cessation counseling and medication management. The primary efficacy outcome will be the proportion of negative urine cannabinoid tests during the 12-week active treatment, compared between groups.

Conditions

Cannabis Use Disorder

Keywords

cannabis; marijuana; youth; adolescent; pharmacotherapy; medication; n-acetylcysteine; trial

Outcome Measures

Primary Outcomes (1)

• Percentage of Urine Tests With Negative Cannabinoid Results During Treatment

  Qualitative urine cannabinoid testing, with cutoff of 50 ng/mL

  Weekly urine cannabinoid tests during 12-week active treatment

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

N-acetylcysteine 1200 mg twice daily for 12 weeks

Drug: N-acetyl cysteine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

N-acetyl cysteine DRUG

N-acetylcysteine 1200 mg twice daily for 12 weeks (administered orally)

N-acetylcysteine

Placebo oral capsule DRUG

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

Placebo

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 14 - 21 years
• 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)
• Must meet current (within last 30 days) DSM-5 criteria for cannabis use disorder
• Must express interest in treatment for cannabis use disorder
• Must submit a positive urine cannabinoid test during screening
• 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

You may not qualify if:

• Allergy or intolerance to N-acetylcysteine
• Females who are pregnant or lactating
• Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)
• Use of carbamazepine or nitroglycerin within 14 days of randomization or expectation of future use during protocol participation
• Current enrollment in treatment for cannabis use disorder or expectation of other treatment during protocol participation
• Any use of synthetic cannabinoids (such as K2/Spice) in the 30 days prior to screening or expectation of future use during protocol participation
• Current moderate or severe substance use disorder, other than cannabis, tobacco, or alcohol
• Medical history of severe asthma (uncontrolled with medications)
• History of seizure disorder
• 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 confound the interpretation of findings

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Related Publications (1)

• Gray KM, Tomko RL, Baker NL, McClure EA, McRae-Clark AL, Squeglia LM. N-acetylcysteine for youth cannabis use disorder: randomized controlled trial main findings. Neuropsychopharmacology. 2025 Apr;50(5):731-738. doi: 10.1038/s41386-025-02061-y. Epub 2025 Feb 5.

  PMID: 39910268 DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kevin M. Gray, M.D.
• Organization: Medical University of South Carolina

graykm@musc.edu

843-792-6330

Study Officials

• Kevin M Gray, MD

  Professor of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind placebo-controlled pharmacotherapy trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Model Details: 1:1 parallel group allocation randomized placebo controlled trial

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: August 3, 2017
• Primary Completion: January 31, 2024
• Study Completion: February 26, 2024
• Last Updated: December 17, 2024
• Results First Posted: December 17, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)