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Sponsors and Collaborators: |
Medical University of South Carolina National Institute on Drug Abuse (NIDA) American Academy of Child Adolescent Psychiatry. |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00542750 |
The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.
Condition | Intervention |
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Cannabis Dependence |
Drug: N-Acetylcysteine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents |
Estimated Enrollment: | 12 |
Arms | Assigned Interventions |
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1: Experimental
All participants will receive N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues will be investigated.
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Drug: N-Acetylcysteine
N-Acetylcysteine 1200 mg twice daily for four weeks
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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:
To assess the safety and tolerability of NAC in cannabis dependent adolescents
The secondary specific aim of the proposed project is:
Primary hypotheses
NAC will be well tolerated among cannabis dependent adolescents.
Secondary hypothesis
Twelve adolescents between 12 and 20 years old will be recruited in this study. Results from this project will be used to design further studies.
Ages Eligible for Study: | 12 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Doug Christie, BS | (843) 792-5453 | christid@musc.edu |
Contact: Kevin M Gray, MD | (843) 792-0135 | graykm@musc.edu |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Doug Christie, BS 843-792-5453 christid@musc.edu | |
Contact: Kevin M Gray, MD (843) 792-0135 graykm@musc.edu |
Principal Investigator: | Kevin M Gray, MD | Medical University of South Carolina |
Study ID Numbers: | 5K12 DA 000357 NAC MJ Pilot |
Study First Received: | October 10, 2007 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00542750 |
Health Authority: | United States: Food and Drug Administration |
Cannabis Marijuana Pharmacotherapy Adolescent |
Mental Disorders Substance-Related Disorders Acetylcysteine |
Disorders of Environmental Origin Marijuana Abuse N-monoacetylcystine |
Anti-Infective Agents Respiratory System Agents Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Expectorants |
Physiological Effects of Drugs Free Radical Scavengers Protective Agents Antiviral Agents Pharmacologic Actions Antidotes |