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N-Acetylcysteine for Youth Cannabis Use Disorder

Primary Purpose

Cannabis Use Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

N-acetyl cysteine

Placebo oral capsule

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring cannabis, marijuana, youth, adolescent, pharmacotherapy, medication, n-acetylcysteine, trial

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-acetylcysteine

Placebo

Arm Description

N-acetylcysteine 1200 mg twice daily for 12 weeks

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

Outcomes

Primary Outcome Measures

Proportion of negative urine cannabinoid tests during treatment

Qualitative urine cannabinoid testing, with cutoff of 50 ng/mL

Secondary Outcome Measures

Full Information

NCT ID

NCT03055377

First Posted

February 14, 2017

Last Updated

July 31, 2023

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT03055377

Brief Title

N-Acetylcysteine for Youth Cannabis Use Disorder

Official Title

N-Acetylcysteine for Youth Cannabis Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 3, 2017 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cannabis Use Disorder

Keywords

cannabis, marijuana, youth, adolescent, pharmacotherapy, medication, n-acetylcysteine, trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

1:1 parallel group allocation randomized placebo controlled trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double-blind placebo-controlled pharmacotherapy trial

Allocation

Randomized

Enrollment

192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

N-acetylcysteine

Arm Type

Experimental

Arm Description

N-acetylcysteine 1200 mg twice daily for 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

N-acetyl cysteine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of negative urine cannabinoid tests during treatment

Description

Qualitative urine cannabinoid testing, with cutoff of 50 ng/mL

Time Frame

Weekly urine cannabinoid tests during 12-week active treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cori Herring, BS

Phone

843-792-8207

herrinco@musc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kevin M Gray, MD

Phone

843-792-6330

graykm@musc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin M Gray, MD

Organizational Affiliation

Professor of Psychiatry and Behavioral Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cori Herring, BS

Phone

843-792-8207

herrinco@musc.edu

First Name & Middle Initial & Last Name & Degree

Kevin Gray, MD

12. IPD Sharing Statement

Plan to Share IPD

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N-Acetylcysteine for Youth Cannabis Use Disorder

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