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Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743119
First Posted: August 28, 2008
Last Update Posted: December 11, 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.
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
Results First Submitted: October 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Conditions: Pain Threshold
Mood
Interventions: Drug: Placebo capsules
Drug: Inactive marijuana (0% THC)
Drug: Low dose Dronabinol
Drug: High dose Dronabinol
Drug: Low THC marijuana
Drug: High THC marijuana

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty-four participants were enrolled, and 30 completed. A total of 30 participants completed all 5 treatment combinations in randomized order.

Reporting Groups
  Description
Placebo/Dronabinol + Marijuana During each session, one capsule containing placebo or dronabinol (10 mg or 20 mg) was administered to the participant 45 min before marijuana was smoked (0, 1.98, or 3.56% THC marijuana). Only one active dose of marijuana or dronabinol was administered within a session. A within-subject design was used in which all participants received all strengths of dronabinol and marijuana. The order was randomized.

Participant Flow:   Overall Study
    Placebo/Dronabinol + Marijuana
STARTED   34 
COMPLETED   30 
NOT COMPLETED   4 
unreliable                3 
Withdrawal by Subject                1 



  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
Overall Number of Baseline Participants 34 participants were enrolled, but only 30 participants completed. Out of the additional 4 volunteers, 1 discontinued for personal reasons and three were unreliable.

Baseline Measures
   Overall Number of Baseline Participants 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      30 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  50.0% 
Male      15  50.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   30 


  Outcome Measures

1.  Primary:   Pain Tolerance   [ Time Frame: Within each session lasting approximately 5 minutes, for a total of five sessions ]


  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
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  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.


Results Point of Contact:  
Name/Title: Dr. Ziva Cooper
Organization: New York State Psychiatric Institute
phone: 646-774-6129
e-mail: zc2160@cumc.columbia.edu


Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743119     History of Changes
Other Study ID Numbers: 5603
5P50DA009236 ( U.S. NIH Grant/Contract )
First Submitted: August 26, 2008
First Posted: August 28, 2008
Results First Submitted: October 20, 2016
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017