Clinical trial NCT03055377: N-Acetylcysteine for Youth Cannabis Use Disorder
Official title: N-Acetylcysteine for Youth Cannabis Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cannabis Use Disorder
Keywords: cannabis
marijuana
youth
adolescent
pharmacotherapy
medication
n-acetylcysteine
trial
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 192
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 parallel group allocation randomized placebo controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Urine Tests With Negative Cannabinoid Results During Treatment
timeFrame: Weekly urine cannabinoid tests during 12-week active treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Professor of Psychiatry and Behavioral Sciences
name: Kevin M Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: