Cannabis and Schizophrenia: Self-Medication and Agonist Treatment
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ClinicalTrials.gov Identifier: NCT00946348 |
Recruitment Status :
Completed
First Posted : July 27, 2009
Results First Posted : September 29, 2014
Last Update Posted : March 14, 2018
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Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborators:
National Institute on Drug Abuse (NIDA)
Indiana University
Columbia University
University of Vermont
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Alan Green, Dartmouth-Hitchcock Medical Center
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science |
Conditions |
Schizophrenia Dual Diagnosis Schizoaffective Disorder Psychotic Disorder Cannabis Use Disorder |
Interventions |
Drug: Dronabinol Drug: Cannabis |
Enrollment | 12 |
Participant Flow
Recruitment Details | Recruitment was conducted through Dartmouth Hitchcock Medical Center, and local community mental health centers. |
Pre-assignment Details | 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. |
Arm/Group Title | Dronabinol | Cannabis |
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Dronabinol 15 mg | Cannabis cigarette (3.6% THC) |
Period Title: Overall Study | ||
Started | 6 | 6 |
Completed | 6 | 6 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Dronabinol | Cannabis | Total | |
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Dronabinol 15 mg | Cannabis cigarette (3.6% THC) | Total of all reporting groups | |
Overall Number of Baseline Participants | 6 | 6 | 12 | |
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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.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 6 participants | 12 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
6 100.0%
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6 100.0%
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12 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 6 participants | 6 participants | 12 participants | |
32.17 (8.32) | 36.2 (9.6) | 34.2 (10.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 6 participants | 12 participants | |
Female |
2 33.3%
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1 16.7%
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3 25.0%
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Male |
4 66.7%
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5 83.3%
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9 75.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 6 participants | 6 participants | 12 participants |
6 | 6 | 12 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Alan I. Green, M.D. |
Organization: | Geisel School of Medicine at Dartmouth |
Phone: | 603-650-7549 |
EMail: | alan.i.green@dartmouth.edu |
Responsible Party: | Alan Green, Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00946348 |
Other Study ID Numbers: |
R01DA013196 ( U.S. NIH Grant/Contract ) 1R01DA026799-01 ( U.S. NIH Grant/Contract ) R01DA013196 ( U.S. NIH Grant/Contract ) R01DA026799-01 ( U.S. NIH Grant/Contract ) DPMC ( Other Identifier: NIDA ) |
First Submitted: | July 24, 2009 |
First Posted: | July 27, 2009 |
Results First Submitted: | April 9, 2014 |
Results First Posted: | September 29, 2014 |
Last Update Posted: | March 14, 2018 |