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

Cannabis Dependence Clinical Trial

Official title:

A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005810
• Other study ID #: 19152
• Secondary ID: R01DA026777
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: November 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse

Intervention

Drug:
• N-Acetylcysteine
1200 mg twice daily for 8 weeks
• placebo
2 capsules twice daily for 8 weeks

Behavioral:
• Contingency Management
rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Negative Urine Cannabinoid Tests During Treatment	[Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100	weekly during treatment, for 8 weeks