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

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ClinicalTrials.gov Identifier: NCT00542750
Recruitment Status : Completed
First Posted : October 11, 2007
Results First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
American Academy of Child Adolescent Psychiatry.
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cannabis Dependence
Intervention Drug: N-Acetylcysteine
Enrollment 24
Recruitment Details 24 participants were recruited over 9 months in 2008-2009.
Pre-assignment Details After informed consent, an assessment/screening visit was used to determine if prospective participants met criteria for inclusion. Briefly, participants were required to be regular cannabis users meeting current criteria for dependence. Participants with unstable psychiatric or medical issues were excluded.
Arm/Group Title N-acetylcysteine
Hide Arm/Group Description All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title N-acetylcysteine
Hide Arm/Group Description All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
19  (0.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
6
  25.0%
Male
18
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period
Hide Description Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine
Hide Arm/Group Description:
All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Participants
24
Time Frame Four weeks (full course of treatment)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-acetylcysteine
Hide Arm/Group Description All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
All-Cause Mortality
N-acetylcysteine
Affected / at Risk (%)
Total   0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
N-acetylcysteine
Affected / at Risk (%) # Events
Total   0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-acetylcysteine
Affected / at Risk (%) # Events
Total   15/24 (62.50%)    
Investigations   
All   15/24 (62.50%)  32
Indicates events were collected by systematic assessment
This was a small, open-label, non-controlled trial, with the associated limitations. A controlled trial is needed to test the effects of N-acetylcysteine relative to placebo.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kevin M. Gray, M.D.
Organization: Medical University of South Carolina
Phone: 8437920135
Responsible Party: Kevin Gray, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00542750     History of Changes
Other Study ID Numbers: 5K12 DA 000357 NAC MJ Pilot
K12DA000357 ( U.S. NIH Grant/Contract )
First Submitted: October 10, 2007
First Posted: October 11, 2007
Results First Submitted: September 23, 2010
Results First Posted: May 23, 2018
Last Update Posted: May 23, 2018