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

October 10, 2007
February 12, 2009
January 2008
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • feasibility of recruitment, measured by number of participants recruited and retained during study period [ Time Frame: one year ]
  • 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) ]
Complete list of historical versions of study NCT00542750 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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) ]
Not Provided
Not Provided
 
An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents
An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents

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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cannabis Dependence
Drug: N-Acetylcysteine
N-Acetylcysteine 1200 mg twice daily for four weeks
Other Name: GNC brand USP-grade NAC (600 mg capsules)
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.
Intervention: Drug: N-Acetylcysteine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
12 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00542750
5K12 DA 000357 NAC MJ Pilot
Yes
Kevin M. Gray, M.D., Medical University of South Carolina
Medical University of South Carolina
  • National Institute on Drug Abuse (NIDA)
  • American Academy of Child Adolescent Psychiatry.
Principal Investigator: Kevin M Gray, MD Medical University of South Carolina
Medical University of South Carolina
February 2009

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