Phase 2 N=116 Randomized Double-blind Treatment

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

Cannabis Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01005810 ↗

Enrolled (actual)

116

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Percentage of Negative Urine Cannabinoid Tests During Treatment — 40.9; 27.2 percentage of negative urine tests — p=0.029

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: N-Acetylcysteine (Drug); placebo (Drug); Contingency Management (Behavioral)
Age: Pediatric, Adult · 13+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Negative Urine Cannabinoid Tests During Treatment	40.9; 27.2	0.029 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01005810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.