N-Acetylcysteine for Youth Cannabis Use Disorder

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT03055377

Collaborator

(none)

192

Enrollment

Location

Arms

78.9

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Use Disorder	Drug: N-acetyl cysteine Drug: Placebo oral capsule	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 parallel group allocation randomized placebo controlled trial1:1 parallel group allocation randomized placebo controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double-blind placebo-controlled pharmacotherapy trial

Primary Purpose:

Treatment

Official Title:

N-Acetylcysteine for Youth Cannabis Use Disorder

Actual Study Start Date :

Aug 3, 2017

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: N-acetylcysteine N-acetylcysteine 1200 mg twice daily for 12 weeks	Drug: N-acetyl cysteine N-acetylcysteine 1200 mg twice daily for 12 weeks (administered orally)
Placebo Comparator: Placebo Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks	Drug: Placebo oral capsule Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)

Arm

Intervention/Treatment

Experimental: N-acetylcysteine

N-acetylcysteine 1200 mg twice daily for 12 weeks

Drug: N-acetyl cysteine

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

Placebo Comparator: Placebo

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

Drug: Placebo oral capsule

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

Outcome Measures

Primary Outcome Measures

Proportion of negative urine cannabinoid tests during treatment [Weekly urine cannabinoid tests during 12-week active treatment]
Qualitative urine cannabinoid testing, with cutoff of 50 ng/mL

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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