Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dronabinol Treatment for Marijuana Addiction (MARINOL)

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.
ClinicalTrials.gov Identifier: NCT00217971
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : November 1, 2011
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, National Institute on Drug Abuse (NIDA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Marijuana Abuse
Interventions Drug: Dronabinol
Drug: Placebo
Enrollment 156
Recruitment Details 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 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.
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description Dronabinol: 20mg bid for a daily maximum dose of 40mg. Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
Period Title: Overall Study
Started 79 77
Completed 55 44
Not Completed 24 33
Reason Not Completed
Adverse Event             1             1
Lost to Follow-up             15             19
Physician Decision             0             1
Withdrawal by Subject             7             12
non compliant             1             0
Arm/Group Title Dronabinol Placebo Total
Hide Arm/Group Description Dronabinol: 20mg bid for a daily maximum dose of 40mg. Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day Total of all reporting groups
Overall Number of Baseline Participants 79 77 156
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 77 participants 156 participants
36.9  (10.8) 38.4  (9.2) 37.9  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 77 participants 156 participants
Female
12
  15.2%
16
  20.8%
28
  17.9%
Male
67
  84.8%
61
  79.2%
128
  82.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 79 participants 77 participants 156 participants
79 77 156
1.Primary Outcome
Title Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial
Hide Description Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.
Time Frame weeks 7 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
Overall Number of Participants Analyzed 79 77
Measure Type: Number
Unit of Measure: participants
14 12
Time Frame Adverse events were assessed 2x/week for 12 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description Dronabinol: 20mg bid for a daily maximum dose of 40mg. Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
All-Cause Mortality
Dronabinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dronabinol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/79 (3.80%)      1/77 (1.30%)    
Endocrine disorders     
diabetes  [1]  1/79 (1.27%)  1 0/77 (0.00%)  0
Gastrointestinal disorders     
stomach flu  [2]  1/79 (1.27%)  1 0/77 (0.00%)  0
Injury, poisoning and procedural complications     
concussion  [3]  1/79 (1.27%)  1 0/77 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
asthma  [4]  0/79 (0.00%)  0 1/77 (1.30%)  1
Indicates events were collected by systematic assessment
[1]
One patient required hospitalization for worsening diabetes after study completion during the follow-up period.
[2]
The fourth patient had a stomach virus and was hospitalized for dehydration and was released after several days.
[3]
One patient was involved in an altercation with the police resulting in a hospitalization with eventual discharge.
[4]
One patient had worsening of chronic asthma that was previously well-controlled, resulting in a brief hospitalization.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dronabinol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/79 (10.13%)      10/77 (12.99%)    
Gastrointestinal disorders     
nausea   5/79 (6.33%)  5 3/77 (3.90%)  3
diarrhea   2/79 (2.53%)  2 6/77 (7.79%)  6
GI upset   4/79 (5.06%)  4 2/77 (2.60%)  2
Indicates events were collected by systematic assessment
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.
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: Frances R Levin, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00217971     History of Changes
Other Study ID Numbers: #4886-NIDA-09236-11
P50DA009236 ( U.S. NIH Grant/Contract )
P50DA009236-11 ( U.S. NIH Grant/Contract )
DPMC
First Submitted: September 16, 2005
First Posted: September 22, 2005
Results First Submitted: September 13, 2011
Results First Posted: November 1, 2011
Last Update Posted: April 24, 2019