Back to resultsA Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
Primary Purpose
Cannabis Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-Acetylcysteine
placebo
Contingency Management
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Dependence
Eligibility Criteria
Inclusion Criteria:
- Age 13-21 years
- Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment
Exclusion Criteria:
- Allergy or intolerance to NAC
- Pregnancy or lactation
- Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation
- Current enrollment in treatment for cannabis dependence
- Current substance dependence, other than cannabis or nicotine
- Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
N-Acetylcysteine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Negative Urine Cannabinoid Tests During Treatment
[Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100
Secondary Outcome Measures
Full Information
NCT ID
NCT01005810
First Posted
September 10, 2009
Last Updated
November 20, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01005810
Brief Title
A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
Official Title
A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.
Detailed Description
This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-Acetylcysteine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
1200 mg twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
2 capsules twice daily for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Primary Outcome Measure Information:
Title
Percentage of Negative Urine Cannabinoid Tests During Treatment
Description
[Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100
Time Frame
weekly during treatment, for 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 13-21 years
Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment
Exclusion Criteria:
Allergy or intolerance to NAC
Pregnancy or lactation
Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation
Current enrollment in treatment for cannabis dependence
Current substance dependence, other than cannabis or nicotine
Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin M Gray, MD
Organizational Affiliation
Medical University of South Carolina
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
12. IPD Sharing Statement
Learn more about this trial
A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
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