Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Dronabinol Treatment for Marijuana Addiction (MARINOL)

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute Identifier:
First received: September 16, 2005
Last updated: April 6, 2016
Last verified: April 2016
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
  Hide Participant Flow

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
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
  Hide 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
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
Overall Participants 
[units: participants]
 79   77   156 
[units: years]
Mean (Standard Deviation)
 36.9  (10.8)   38.4  (9.2)   37.9  (10.1) 
[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

  Limitations and Caveats
  Hide 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.

  More Information
  Hide 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: Frances R. Levin, M.D.
Organization: Columbia University
phone: (212) 543-5896

Responsible Party: New York State Psychiatric Institute Identifier: NCT00217971     History of Changes
Other Study ID Numbers: #4886-NIDA-09236-11
P50DA009236 ( US NIH Grant/Contract Award Number )
P50DA009236-11 ( US NIH Grant/Contract Award Number )
Study First Received: September 16, 2005
Results First Received: September 13, 2011
Last Updated: April 6, 2016
Health Authority: United States: Food and Drug Administration