N-Acetylcysteine for Youth Cannabis Use Disorder

Phase 2

Completed

• Conditions: Cannabis Use Disorder
• Interventions: Drug: N-acetyl cysteine; Drug: Placebo oral capsule

• Registration Number: NCT03055377
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Cannabis use is particularly prevalent and problematic among youth. Compared with only one in eleven cannabis-exposed adults, one in six cannabis-exposed youth develops cannabis use disorder. Moreover, youth are more prone than adults to potentially lasting adverse effects of cannabis use, including cognitive impairment, altered brain development, poor educational outcome, and diminished life achievement. Despite this, relatively little work has focused on developing optimally efficacious cannabis use disorder treatments, particularly among youth. Current evidence-based treatments convey generally small to modest effect sizes, and novel approaches are critically needed. Among the most promising approaches is the over-the-counter antioxidant medication N-acetylcysteine (NAC). Our team previously demonstrated superior NAC versus placebo (PBO) abstinence outcomes in youth with CUD who concurrently received the behavioral treatment contingency management (CM). Further work is now needed to test whether NAC is efficacious without a platform of CM. The proposed trial 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. We will also serially assess cognitive task performance, examining changes in performance among participants who achieve abstinence versus those that do not. This proposed trial is the clear "next step" in the assessment of NAC as an extremely promising youth CUD treatment modality, and is positioned to inform researchers, clinicians, and the general public, addressing a critical need for optimization of youth CUD treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-16
• Study Start: 2017-08-03
• Primary Completion: 2024-01-31
• Study Completion: 2024-02-26
• Status Verified: 2024-11
• Results First Submitted: 2024-11-06
• Results First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Results First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine	N-acetyl cysteine	N-acetylcysteine 1200 mg twice daily for 12 weeks
Placebo	Placebo oral capsule	Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Urine Tests With Negative Cannabinoid Results During Treatment	Weekly urine cannabinoid tests during 12-week active treatment	Qualitative urine cannabinoid testing, with cutoff of 50 ng/mL

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States