Dronabinol Treatment for Marijuana Addiction (MARINOL)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00217971
First received: September 16, 2005
Last updated: June 28, 2012
Last verified: June 2012
Results First Received: September 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Marijuana Abuse
Interventions: Drug: Dronabinol
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
All participants were seeking outpatient treatment for problems related to marijuana use and were recruited by local advertising or by clinical referrals in the New York City metropolitan area. Recruitment ran from 3/05-8/09 and patients participated in the trial at a research clinic at Columbia University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial included a one-week placebo lead-in phase. Individuals who were able to significantly decrease their marijuana use during the first week of the study were not randomized. Participants who reported marijuana use less than twice a week during the placebo lead-in phase were considered placebo responders.

Reporting Groups
  Description
Dronabinol Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Placebo Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day

Participant Flow:   Overall Study
    Dronabinol     Placebo  
STARTED     79     77  
COMPLETED     55     44  
NOT COMPLETED     24     33  
Adverse Event                 1                 1  
Lost to Follow-up                 15                 19  
Physician Decision                 0                 1  
Withdrawal by Subject                 7                 12  
non compliant                 1                 0  



  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
Dronabinol Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Placebo Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
Total Total of all reporting groups

Baseline Measures
    Dronabinol     Placebo     Total  
Number of Participants  
[units: participants]
  79     77     156  
Age  
[units: years]
Mean ± Standard Deviation
  36.9  ± 10.8     38.4  ± 9.2     37.9  ± 10.1  
Gender  
[units: participants]
     
Female     12     16     28  
Male     67     61     128  
Region of Enrollment  
[units: participants]
     
United States     79     77     156  



  Outcome Measures

1.  Primary:   Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial   [ Time Frame: weeks 7 and 8 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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
Consequences of use are often long-term and more subtle. Thus, trying to initiate change over a relatively short period (i.e. patients in the present trial were maintained on the maximum dronabinol dose for only 6 weeks), may have been inadequate.  


Results Point of Contact:  
Name/Title: Frances R. Levin, M.D.
Organization: Columbia University
phone: (212) 543-5896
e-mail: frl2@columbia.edu


No publications provided


Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00217971     History of Changes
Other Study ID Numbers: #4886-NIDA-09236-11, P50DA009236, P50DA009236-11, DPMC
Study First Received: September 16, 2005
Results First Received: September 13, 2011
Last Updated: June 28, 2012
Health Authority: United States: Food and Drug Administration