A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana

Phase 2

Completed

• Conditions: Cannabis Dependence
• Interventions: Drug: placebo; Drug: N-Acetylcysteine; Behavioral: Contingency Management

• Registration Number: NCT01005810
• Lead Sponsor: Medical University of South Carolina

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2018-04-23
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-20
• Last Update Submitted: 2018-11-20
• Results First Posted: 2018-11-21
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Contingency Management	-
N-Acetylcysteine	Contingency Management	-
Placebo	placebo	-
N-Acetylcysteine	N-Acetylcysteine	-

Primary Outcome Measures

Name	Time	Method
Percentage of Negative Urine Cannabinoid Tests During Treatment	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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States