N-Acetylcysteine for Youth Cannabis Use Disorder

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

1. Age 14 - 21 years

2. 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)

3. Must meet current (within last 30 days) DSM-5 criteria for cannabis use disorder

4. Must express interest in treatment for cannabis use disorder

5. Must submit a positive urine cannabinoid test during screening

6. 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:

1. Allergy or intolerance to N-acetylcysteine

2. Females who are pregnant or lactating

3. Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)

4. Use of carbamazepine or nitroglycerin within 14 days of randomization or expectation of future use during protocol participation

5. Current enrollment in treatment for cannabis use disorder or expectation of other treatment during protocol participation

6. Any use of synthetic cannabinoids (such as K2/Spice) in the 30 days prior to screening or expectation of future use during protocol participation

7. Current moderate or severe substance use disorder, other than cannabis, tobacco, or alcohol

8. Medical history of severe asthma (uncontrolled with medications)

9. History of seizure disorder

10. 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