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

Medical University of South Carolina116 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

116

Conditions

Cannabis Dependence

Interventions

N-AcetylcysteineDRUG

1200 mg twice daily for 8 weeks

placeboDRUG

2 capsules twice daily for 8 weeks

Contingency ManagementBEHAVIORAL

rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Eligibility

Sex: ALLMin age: 13 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: weekly during treatment, for 8 weeks

Data from ClinicalTrials.gov

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