Investigator: Kevin M. Gray, M.D. (Medical University of South Carolina)
Release Date: TBA
Abstract: This study is a 12-week, double-blind, randomized, placebo controlled trial of N-acetylcysteine (NAC) 1200mg twice daily, added to contingency management (CM), for the treatment of cannabis use among treatment-seeking cannabis-dependent adults (18-60). Approximately 300 participants will be randomized into this 6-site study. Participants will be asked to have a single blood draw performed for the purpose of future genetic analysis. Participants will have twice weekly study visits for 12 weeks, followed by a single follow up visit, approximately 16 weeks after randomization. All participants will concurrently receive CM twice weekly during treatment, including escalating schedules of cash reinforcement with resets, targeting (a) retention, and (b) cannabis abstinence (confirmed by negative qualitative urine cannabinoid testing). Medication management will be conducted by the medical clinician weekly throughout treatment. Assessments include Timeline Follow-Back and urine cannabinoid testing (qualitative and creatinine-normalized quantitative). Secondary measures include, but are not limited to, cannabis craving (Marijuana Craving Questionnaire), cannabis withdrawal (Cannabis Withdrawal Scale), compulsive drug symptoms (Obsessive Compulsive Drug Use Scale), cannabis associated problems (Marijuana Problem Scale), depression/anxiety symptoms (Hospital Anxiety and Depression Scale), sleep quality (Pittsburgh Sleep Quality Index), and quality of life (PhenX Toolkit assessment). Medication adherence will be assessed using self-report, blister pack pill counts, and urine riboflavin testing. The primary analysis will evaluate the impact of NAC versus PBO on cannabis use during the 12-week treatment intervention. The primary outcome measure is odds of negative urine cannabinoid tests submitted during active treatment, compared between treatment groups.
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