Dronabinol Interactions in Humans

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00842985
First received: February 11, 2009
Last updated: November 15, 2012
Last verified: November 2012
Results First Received: August 5, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Cannabis
Marijuana Abuse
Interventions: Drug: Dronabinol + Modafinil
Drug: Dronabinol + Placebo
Drug: Placebo + Modafinil
Drug: Placebo + 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
No text entered.

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
All Participants

There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.

Not all participants received the interventions in the same order.


Participant Flow for 8 periods

Period 1:   Screening
    All Participants  
STARTED     53  
COMPLETED     26  
NOT COMPLETED     27  
Did not meet entrance requirements                 27  

Period 2:   First Intervention
    All Participants  
STARTED     26 [1]
COMPLETED     20 [2]
NOT COMPLETED     6  
Withdrawal by Subject                 3  
Protocol Violation                 3  
[1] Signed Consent
[2] Completed 1st Intervention

Period 3:   Washout Period of GE 4 Days
    All Participants  
STARTED     20  
COMPLETED     18  
NOT COMPLETED     2  
Withdrawal by Subject                 2  

Period 4:   Second Intervention
    All Participants  
STARTED     18  
COMPLETED     17  
NOT COMPLETED     1  

Period 5:   Washout Period of GE 4 Days
    All Participants  
STARTED     17  
COMPLETED     15  
NOT COMPLETED     2  
Withdrawal by Subject                 2  

Period 6:   Third Intervention
    All Participants  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  

Period 7:   Washout Period of GE 4 Days
    All Participants  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  

Period 8:   Fourth Intervention
    All Participants  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     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
All Participants

There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.

Not all participants received the interventions in the same order.


Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  53  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     53  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  33.7  ± 7.7  
Gender  
[units: participants]
 
Female     11  
Male     42  
Region of Enrollment  
[units: participants]
 
United States     53  



  Outcome Measures

1.  Primary:   CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing   [ Time Frame: Once for each test session (4 total). ]


  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

One dose of modafinil Brief treatment duration and use of a low dose of THC Cognitive testing assessed only two tasks. Outcome measures were limited by small sample size.

Limited generalizability because heavy cannibas users were excluded

 


Results Point of Contact:  
Name/Title: Mehmet Sofuoglu, M.D., Ph.D.
Organization: Yale University
phone: 203-937-4809
e-mail: mehmet.sofuoglu@yale.edu


Publications of Results:

Responsible Party: Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier: NCT00842985     History of Changes
Other Study ID Numbers: 0702002357, MIRECC 00000000, P50DA009241
Study First Received: February 11, 2009
Results First Received: August 5, 2011
Last Updated: November 15, 2012
Health Authority: United States: Federal Government