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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
24 participants were recruited over 9 months in 2008-2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
N-acetylcysteine All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.

Participant Flow:   Overall Study
    N-acetylcysteine
STARTED   24 
COMPLETED   24 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
N-acetylcysteine All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.

Baseline Measures
   N-acetylcysteine 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      24 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 19  (0.78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  25.0% 
Male      18  75.0% 
Region of Enrollment 
[Units: Participants]
 
United States   24 


  Outcome Measures

1.  Primary:   Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period   [ Time Frame: one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: graykm@musc.edu



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