Phase 3
N=192
N-Acetylcysteine for Youth Cannabis Use Disorder
Cannabis Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03055377 ↗Enrolled (actual)
192
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Percentage of Urine Tests With Negative Cannabinoid Results During Treatment — 9.4; 14.0 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- N-acetyl cysteine (Drug); Placebo oral capsule (Drug)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Urine Tests With Negative Cannabinoid Results During Treatment |
9.4; 14.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03055377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.