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Trial record 22 of 94 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

N-Acetylcysteine for Youth Cannabis Use Disorder

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ClinicalTrials.gov Identifier: NCT03055377
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Kevin Gray, MD, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 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 : June 1, 2017
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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)




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055377


Contacts
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Contact: Lori Ann Ueberroth, BS 843-792-8220 ueberro@musc.edu
Contact: Kevin M Gray, MD 843-792-6330 graykm@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Contact: Lori Ann Ueberroth    843-792-8220    ueberro@musc.edu   
Principal Investigator: Kevin Gray, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Kevin M Gray, MD Professor of Psychiatry and Behavioral Sciences

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Responsible Party: Kevin Gray, MD, Professor of Psychiatry and Behavioral Sciences, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03055377     History of Changes
Other Study ID Numbers: Pro00054499
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kevin Gray, MD, Medical University of South Carolina:
cannabis
marijuana
youth
adolescent
pharmacotherapy
medication
n-acetylcysteine
trial

Additional relevant MeSH terms:
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Marijuana Abuse
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes