Cannabis and Schizophrenia: Self-Medication and Agonist Treatment

This study has been completed.
Sponsor:
Collaborators:
Indiana University
Columbia University
University of Vermont
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00946348
First received: July 24, 2009
Last updated: September 26, 2014
Last verified: September 2014
Results First Received: April 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Schizophrenia
Dual Diagnosis
Schizoaffective Disorder
Psychotic Disorder
Cannabis Use Disorder
Interventions: Drug: Dronabinol
Drug: Cannabis

  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
Recruitment was conducted through Dartmouth Hitchcock Medical Center, and local community mental health centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 52 people who consented to participate in the study, 12 met eligibility criteria for the main study and were randomized. Because persons who met entry criteria received study treatment on only one day, all randomized participants completed the study.

Reporting Groups
  Description
Dronabinol Dronabinol 15 mg
Cannabis Cannabis cigarette (3.6% THC)

Participant Flow:   Overall Study
    Dronabinol     Cannabis  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     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.
52 subjects consented; 15 were in a pilot study to determine the dose of dronabinol and strength of the marijuana cigarette and 14 were health controls (who received no drug)for comparison. The remaining 23 subjects consented to the Main Study and 12 were met eligibility criteria and were randomized to receive dronabinol or a marijuana cigarette.

Reporting Groups
  Description
Dronabinol Dronabinol 15 mg
Cannabis Cannabis cigarette (3.6% THC)
Total Total of all reporting groups

Baseline Measures
    Dronabinol     Cannabis     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.17  ± 8.32     36.2  ± 9.6     34.2  ± 10.6  
Gender  
[units: participants]
     
Female     2     1     3  
Male     4     5     9  
Region of Enrollment  
[units: participants]
     
United States     6     6     12  



  Outcome Measures

1.  Primary:   fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).   [ Time Frame: Measures were acquired at peak THC level for each of the two drugs up to 4 hours. ]

2.  Secondary:   To Assess the Effects of Dronabinol in This Population to Determine Whether Measures of Craving, Mood and Negative Symptoms Will Improve Using the PANSS; and to Determine Whether Measures of Psychotic Symptoms and Cognitive Deficits Will Increase.   [ Time Frame: Over 8 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Alan I. Green, M.D.
Organization: Geisel School of Medicine at Dartmouth
phone: 603-650-7549
e-mail: alan.i.green@dartmouth.edu


No publications provided


Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00946348     History of Changes
Other Study ID Numbers: R01 DA013196, 1R01DA026799-01, R01DA013196, R01DA026799-01, DPMC
Study First Received: July 24, 2009
Results First Received: April 9, 2014
Last Updated: September 26, 2014
Health Authority: United States: Federal Government