A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents

Conditions
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Cannabis Dependence

Intervention / Treatment
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* Drug: N-Acetylcysteine
* Drug: placebo
* Behavioral: Contingency Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-Acetylcysteine<br> | Drug: N-Acetylcysteine<br>* 1200 mg twice daily for 8 weeks<br>* Other names: NAC;Behavioral: Contingency Management<br>* rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* 2 capsules twice daily for 8 weeks<br>Behavioral: Contingency Management<br>* rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | weekly during treatment, for 8 weeks |