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

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ClinicalTrials.gov Identifier: NCT01005810
Recruitment Status : Completed
First Posted : November 2, 2009
Results First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

Brief 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.

Condition or disease Intervention/treatment Phase
Cannabis Dependence Drug: N-Acetylcysteine Drug: placebo Behavioral: Contingency Management Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents
Study Start Date : September 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percentage of Negative Urine Cannabinoid Tests During Treatment [ Time Frame: weekly during treatment, for 8 weeks ]
    [Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005810


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kevin M Gray, MD Medical University of South Carolina

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Responsible Party: Kevin Gray, MD, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01005810     History of Changes
Other Study ID Numbers: 19152
R01DA026777 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2009    Key Record Dates
Results First Posted: November 21, 2018
Last Update Posted: November 21, 2018
Last Verified: November 2018

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