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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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Medical University of South Carolina.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005810
First Posted: November 2, 2009
Last Update Posted: November 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of South Carolina
September 10, 2009
November 2, 2009
November 2, 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 ]
Same as current
No Changes Posted
  • Daily self-report of marijuana use (amount per day and number of days of use per week) [ Time Frame: 12 weeks ]
  • Creatinine-normalized quantitative urine cannabinoid level [ Time Frame: weekly for 2 weeks, then bi-weekly for eight weeks, and at 12 weeks ]
  • Time to first negative urine cannabinoid test [ Time Frame: weekly for 2 weeks, then bi-weekly for eight weeks, and at 12 weeks ]
  • Marijuana craving and withdrawal measures [ Time Frame: weekly for 10 weeks and at week 12 ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
 
Unknown status
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
Sexes Eligible for Study: All
13 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01005810
19152
R01DA026777 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
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