NCT00542750

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 12 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cannabis Dependence

Interventions

Type	Name	Description
DRUG	N-Acetylcysteine	N-Acetylcysteine 1200 mg twice daily for four weeks

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-10-11
• Last updated: 2018-05-23
• Results posted: 2018-05-23

Locations

1 site across 1 country: United States