A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Percentage of Negative Urine Cannabinoid Tests During Treatment
Overview
Brief Summary
This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.
Detailed Description
This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 13 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 13-21 years
- •Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment
Exclusion Criteria
- •Allergy or intolerance to NAC
- •Pregnancy or lactation
- •Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation
- •Current enrollment in treatment for cannabis dependence
- •Current substance dependence, other than cannabis or nicotine
- •Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician
Arms & Interventions
N-Acetylcysteine
Intervention: N-Acetylcysteine (Drug)
N-Acetylcysteine
Intervention: Contingency Management (Behavioral)
Placebo
Intervention: placebo (Drug)
Placebo
Intervention: Contingency Management (Behavioral)
Outcomes
Primary Outcomes
Percentage of Negative Urine Cannabinoid Tests During Treatment
Time Frame: weekly during treatment, for 8 weeks
\[Total number of negative urine tests per Group divided by the total number of urine tests per Group\]\*100
Secondary Outcomes
No secondary outcomes reported
Investigators
Kevin Gray, MD
Associate Professor
Medical University of South Carolina