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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01005810
First received: September 10, 2009
Last updated: October 30, 2009
Last verified: October 2009

September 10, 2009
October 30, 2009
September 2009
July 2011   (final data collection date for primary outcome measure)
Number of negative urine cannabinoid tests [ Time Frame: weekly for 2 weeks, then bi-weekly for eight weeks, and at 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01005810 on ClinicalTrials.gov Archive Site
  • Daily self-report of marijuana use (amount per day and number of days of use per week) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Creatinine-normalized quantitative urine cannabinoid level [ Time Frame: weekly for 2 weeks, then bi-weekly for eight weeks, and at 12 weeks ] [ Designated as safety issue: No ]
  • Time to first negative urine cannabinoid test [ Time Frame: weekly for 2 weeks, then bi-weekly for eight weeks, and at 12 weeks ] [ Designated as safety issue: No ]
  • Marijuana craving and withdrawal measures [ Time Frame: weekly for 10 weeks and at week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cannabis Dependence
  • Drug: N-Acetylcysteine
    1200 mg twice daily for 8 weeks
    Other Name: NAC
  • Drug: placebo
    2 capsules twice daily for 8 weeks
  • Behavioral: Contingency Management
    rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
  • Active Comparator: N-Acetylcysteine
    Interventions:
    • Drug: N-Acetylcysteine
    • Behavioral: Contingency Management
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: placebo
    • Behavioral: Contingency Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
13 Years to 21 Years
No
United States
 
NCT01005810
19152, R01 DA026777
Yes
Kevin M. Gray, MD, Medical University of South Carolina
Medical University of South Carolina
Not Provided
Principal Investigator: Kevin M Gray, MD Medical University of South Carolina
Medical University of South Carolina
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP