Dronabinol Interactions in Humans

This study has been completed.
Sponsor:
Collaborators:
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00842985
First received: February 11, 2009
Last updated: October 13, 2016
Last verified: November 2012
Results First Received: August 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   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 
Overall Participants Analyzed 
[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


  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

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



  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: 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 ( Registry Identifier: Veteran's Administration )
P50DA009241 ( US NIH Grant/Contract Award Number )
Study First Received: February 11, 2009
Results First Received: August 5, 2011
Last Updated: October 13, 2016