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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Cannabis Dependence
 Drug: N-Acetylcysteine
Drug: placebo
Behavioral: Contingency Management
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: September 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: N-Acetylcysteine Drug: N-Acetylcysteine
1200 mg twice daily for 8 weeks
Other Name: NAC
Behavioral: Contingency Management
rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Placebo Comparator: Placebo 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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005810

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Contact: Sarah Farber, B.S.     843-792-5453     farbers@musc.edu    
Contact: Christine Horne, B.S.     843-792-5807     hornechr@musc.edu    
Principal Investigator: Kevin M Gray, M.D.            
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kevin M Gray, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Kevin M. Gray, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01005810     History of Changes
Other Study ID Numbers: 19152, R01 DA026777
Study First Received: September 10, 2009
Last Updated: October 30, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on June 17, 2013