An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents (NAC MJ Pilot)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents|
- feasibility of recruitment, measured by number of participants recruited and retained during study period [ Time Frame: one year ] [ Designated as safety issue: No ]
- tolerability of study medication, measured by adverse events documentation and a checklist of adverse events (MOSES scale) [ Time Frame: one year (tracked throughout the four weeks of study participation for each participant) ] [ Designated as safety issue: Yes ]
- marijuana use rate during participation as compared to use rate prior to participation, as recorded in marijuana diary and Timeline Follow-Back [ Time Frame: for each participant, compare four weeks prior to participation with four weeks during participation ] [ Designated as safety issue: No ]
- difference in reactivity to marijuana cues between pre-medication and medication conditions, measured by Marijuana Craving Questionnaire and physiologic data (skin conductance and heart rate) [ Time Frame: 2 cue sessions for each subject (data collected throughout this one year study) ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
N-Acetylcysteine 1200 mg twice daily for four weeks
Other Name: GNC brand USP-grade NAC (600 mg capsules)
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 feasibility of conducting a trial of NAC in cannabis dependent adolescents.
To assess the safety and tolerability of NAC in cannabis dependent adolescents
The secondary specific aim of the proposed project is:
- To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
- It will be feasible to recruit and retain cannabis dependent adolescents in a trial of NAC.
NAC will be well tolerated among cannabis dependent adolescents.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542750
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Kevin M Gray, MD||Medical University of South Carolina|