An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents

Status Completed

Clinical Trial Summary

The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.

Clinical Trial Description

This project involves investigation of oral N-acetylcysteine (NAC) as a potential pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence continues to be a major problem among adolescents in the United States. To date, psychosocial interventions have produced only small to modest effect sizes in controlled trials, and minimal work has been done to investigate the potential role for pharmacotherapy for cannabis dependence. Translating preclinical research suggesting a role for NAC in cocaine dependent individuals, our research group has developed preliminary evidence of decreased cocaine use and cue reactivity in humans taking NAC. Preclinical research has additionally demonstrated significant parallels in glutamatergic dysfunction in the nucleus accumbens (the proposed target of NAC treatment) between habitual cocaine and marijuana users. NAC is an inexpensive, long-available agent with a favorable tolerability profile in adults and children. However, it has not yet been studied in cannabis dependent adolescents. Hence, we are undertaking an open-label pilot trial of NAC in adolescents with cannabis dependence.

The primary specific aims of the proposed project are:

1. To assess the feasibility of conducting a trial of NAC in cannabis dependent adolescents.

2. To assess the safety and tolerability of NAC in cannabis dependent adolescents

The secondary specific aim of the proposed project is:

3. To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.

Primary hypotheses

1. It will be feasible to recruit and retain cannabis dependent adolescents in a trial of NAC.

2. NAC will be well tolerated among cannabis dependent adolescents.

Secondary hypothesis

3. Adequate variability information will be gathered to design a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.

Twenty-four adolescents between 12 and 20 years old will be recruited in this study. Results from this project will be used to design further studies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00542750
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	January 2008
Completion date	December 2008

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents — NAC MJ Pilot

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms