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Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment (ACCENT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01675661
First Posted: August 30, 2012
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kevin Gray, Medical University of South Carolina
Results First Submitted: January 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cannabis Dependence
Interventions: Drug: N-Acetylcysteine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred almost exclusively through advertising. Individuals currently in treatment for cannabis dependence were not eligible to participate

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
NAC Plus CM

N-acetylcysteine (NAC) plus Contingency Management (CM)

N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Placebo Plus CM

Placebo plus Contingency Management (CM)

Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.


Participant Flow:   Overall Study
    NAC Plus CM   Placebo Plus CM
STARTED   153   149 
COMPLETED   113   103 
NOT COMPLETED   40   46 
Lost to Follow-up                22                23 
Practical problems                9                5 
Moved away                5                6 
Withdrawal by Subject                3                7 
Physician Decision                0                2 
Death                0                1 
Other reason                1                2 



  Baseline Characteristics
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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
NAC Plus CM

N-acetylcysteine (NAC) plus Contingency Management (CM)

N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Placebo Plus CM

Placebo plus Contingency Management (CM)

Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Total Total of all reporting groups

Baseline Measures
   NAC Plus CM   Placebo Plus CM   Total 
Overall Participants Analyzed 
[Units: Participants]
 153   149   302 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.8  (8.74)   30.8  (9.32)   30.3  (9.03) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      36  23.5%      50  33.6%      86  28.5% 
Male      117  76.5%      99  66.4%      216  71.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      31  20.3%      34  22.8%      65  21.5% 
Not Hispanic or Latino      122  79.7%      115  77.2%      237  78.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      2   1.3%      2   0.7% 
Asian      1   0.7%      2   1.3%      3   1.0% 
Native Hawaiian or Other Pacific Islander      1   0.7%      0   0.0%      1   0.3% 
Black or African American      44  28.8%      40  26.8%      84  27.8% 
White      84  54.9%      92  61.7%      176  58.3% 
More than one race      13   8.5%      6   4.0%      19   6.3% 
Unknown or Not Reported      10   6.5%      7   4.7%      17   5.6% 
Region of Enrollment 
[Units: Participants]
     
United States   153   149   302 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Odds of Negative Urine Cannabinoid Tests During Treatment.   [ Time Frame: study weeks 2-13 ]

2.  Secondary:   End-of-treatment Cannabis Abstinence, Measured by Negative Cannabinoid Testing for the Last Four Weeks of Treatment.   [ Time Frame: Study Days 57-84 ]

3.  Secondary:   Effect of Baseline Smoking Status on Cannabis Negative Urine Drug Screens   [ Time Frame: Study weeks 2-13 ]

4.  Secondary:   Quality of Life   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Kevin Gray, MD
Organization: Medical University of South Carolina
phone: 843-792-6330
e-mail: graykm@musc.edu


Publications:

Responsible Party: Kevin Gray, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01675661     History of Changes
Other Study ID Numbers: CTN-0053
U10DA013727 ( U.S. NIH Grant/Contract )
UG1DA013727 ( U.S. NIH Grant/Contract )
U10DA013045 ( U.S. NIH Grant/Contract )
U10DA015815 ( U.S. NIH Grant/Contract )
U10DA013732 ( U.S. NIH Grant/Contract )
U10DA015831 ( U.S. NIH Grant/Contract )
U10DA020024 ( U.S. NIH Grant/Contract )
First Submitted: August 19, 2012
First Posted: August 30, 2012
Results First Submitted: January 18, 2017
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017