An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents (NAC MJ Pilot)

This study has been completed.
Sponsor:
Collaborators:
American Academy of Child Adolescent Psychiatry.
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00542750
First received: October 10, 2007
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.


Condition Intervention Phase
Cannabis Dependence
Drug: N-Acetylcysteine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents

Resource links provided by NLM:


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

Primary Outcome Measures:
  • feasibility of recruitment, measured by number of participants recruited and retained during study period [ Time Frame: one year ] [ Designated as safety issue: No ]
  • tolerability of study medication, measured by adverse events documentation and a checklist of adverse events (MOSES scale) [ Time Frame: one year (tracked throughout the four weeks of study participation for each participant) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • marijuana use rate during participation as compared to use rate prior to participation, as recorded in marijuana diary and Timeline Follow-Back [ Time Frame: for each participant, compare four weeks prior to participation with four weeks during participation ] [ Designated as safety issue: No ]
  • difference in reactivity to marijuana cues between pre-medication and medication conditions, measured by Marijuana Craving Questionnaire and physiologic data (skin conductance and heart rate) [ Time Frame: 2 cue sessions for each subject (data collected throughout this one year study) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All participants will receive N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues will be investigated.
Drug: N-Acetylcysteine
N-Acetylcysteine 1200 mg twice daily for four weeks
Other Name: GNC brand USP-grade NAC (600 mg capsules)

Detailed Description:

This project involves investigation of oral N-acetylcysteine (NAC) as a potential pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence continues to be a major problem among adolescents in the United States. To date, psychosocial interventions have produced only small to modest effect sizes in controlled trials, and minimal work has been done to investigate the potential role for pharmacotherapy for cannabis dependence. Translating preclinical research suggesting a role for NAC in cocaine dependent individuals, our research group has developed preliminary evidence of decreased cocaine use and cue reactivity in humans taking NAC. Preclinical research has additionally demonstrated significant parallels in glutamatergic dysfunction in the nucleus accumbens (the proposed target of NAC treatment) between habitual cocaine and marijuana users. NAC is an inexpensive, long-available agent with a favorable tolerability profile in adults and children. However, it has not yet been studied in cannabis dependent adolescents. Hence, we are undertaking an open-label pilot trial of NAC in adolescents with cannabis dependence.

The primary specific aims of the proposed project are:

  1. To assess the feasibility of conducting a trial of NAC in cannabis dependent adolescents.
  2. To assess the safety and tolerability of NAC in cannabis dependent adolescents

    The secondary specific aim of the proposed project is:

  3. To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.

Primary hypotheses

  1. It will be feasible to recruit and retain cannabis dependent adolescents in a trial of NAC.
  2. NAC will be well tolerated among cannabis dependent adolescents.

    Secondary hypothesis

  3. Adequate variability information will be gathered to design a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.

Twenty-four adolescents between 12 and 20 years old will be recruited in this study. Results from this project will be used to design further studies.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 12 - 20 years old.
  • Participants must be regular smokers of marijuana (on average smoke at least 3 times per week for at least one year) and meet DSM-IV Criteria for cannabis dependence, with desire to cut down on marijuana use.
  • Participants must understand all oral and written informed consent and give such consent prior to on-site screening.
  • Participants must agree to refrain from marijuana use for 24 hours prior to each cue reactivity session (Visits 2 and 4).
  • Participants must have a person that can be contacted in case of emergency.
  • Participants must have had stable residence for the past 30 days.
  • Post-menarchal female participants must agree to use birth control to avoid pregnancy.

Exclusion Criteria:

  • Allergy or intolerance to N-Acetylcysteine (NAC).
  • Pregnancy or lactation.
  • History of seizures.
  • Current or past history of asthma and/or the occasional or daily use of albuterol or other beta-agonist inhalers.
  • Current use of medications that might affect heart rate or skin conductance.
  • Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study.
  • History of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction,), stroke, seizure, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, metabolic, or other disorders that may place the participant at increased risk per the judgment of the study physician.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542750

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
American Academy of Child Adolescent Psychiatry.
Investigators
Principal Investigator: Kevin M Gray, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Kevin M. Gray, M.D., Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00542750     History of Changes
Other Study ID Numbers: 5K12 DA 000357 NAC MJ Pilot
Study First Received: October 10, 2007
Last Updated: February 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Cannabis
Marijuana
Pharmacotherapy
Adolescent

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced 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 August 26, 2014