- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055377
N-Acetylcysteine for Youth Cannabis Use Disorder
February 26, 2024 updated by: Kevin Gray, MD, Medical University of South Carolina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
192
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cori Herring, BS
- Phone Number: 843-792-8207
- Email: herrinco@musc.edu
Study Contact Backup
- Name: Kevin M Gray, MD
- Phone Number: 843-792-6330
- Email: graykm@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29403
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: N-acetylcysteine
N-acetylcysteine 1200 mg twice daily for 12 weeks
|
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
|
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of negative urine cannabinoid tests during treatment
Time Frame: Weekly urine cannabinoid tests during 12-week active treatment
|
Qualitative urine cannabinoid testing, with cutoff of 50 ng/mL
|
Weekly urine cannabinoid tests during 12-week active treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kevin M Gray, MD, Professor of Psychiatry and Behavioral Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2017
Primary Completion (Actual)
January 31, 2024
Study Completion (Actual)
February 26, 2024
Study Registration Dates
First Submitted
February 14, 2017
First Submitted That Met QC Criteria
February 15, 2017
First Posted (Actual)
February 16, 2017
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Marijuana Abuse
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- Pro00054499
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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