Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cannabis and Schizophrenia: Self-Medication and Agonist Treatment

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.
 
ClinicalTrials.gov Identifier: NCT00946348
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : September 29, 2014
Last Update Posted : March 14, 2018
Sponsor:
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

Study Type Interventional
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
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
Hide Arm/Group Description Dronabinol 15 mg Cannabis cigarette (3.6% THC)
Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Dronabinol Cannabis Total
Hide Arm/Group Description Dronabinol 15 mg Cannabis cigarette (3.6% THC) Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 6 participants 6 participants 12 participants
Female
2
  33.3%
1
  16.7%
3
  25.0%
Male
4
  66.7%
5
  83.3%
9
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).
Hide Description Average Z scores for the region-of-interest functional connectivity at the second scan (when subjects received either a cannabis cigarette or 15mg of dronabinol) between the bilateral nucleus accumbens (NAc) and ventral anterior cingulate cortex (vACC) for patients with schizophrenia and co-occurring cannabis use disorder.
Time Frame Measures were acquired at peak THC level for each of the two drugs up to 4 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Cannabis
Hide Arm/Group Description:
Dronabinol 15 mg
Cannabis cigarette (3.6% THC)
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Z score
.40  (.85) .33  (.38)
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Over 8 hours
Outcome Measure Data Not Reported
Time Frame Adverse events were recorded from the date of consent through the final telephone contact with the patient after the second scan. Though the time differed based on scheduling of patients, it was typically 4-5 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dronabinol Cannabis
Hide Arm/Group Description Dronabinol 15 mg Cannabis cigarette (3.6% THC)
All-Cause Mortality
Dronabinol Cannabis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Dronabinol Cannabis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dronabinol Cannabis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      3/6 (50.00%)    
Gastrointestinal disorders     
Less Appetite  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Psychiatric disorders     
Cannabis Withdrawal  1 [1]  2/6 (33.33%)  5 3/6 (50.00%)  11
Anxiety  1  1/6 (16.67%)  1 1/6 (16.67%)  1
Increased Psychiatric Symptoms  1 [2]  0/6 (0.00%)  0 1/6 (16.67%)  1
Decreased Sleep  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Source Vocabulary
[1]
This was assessed using the Cannabis Withdrawal Assessment Scale at each visit. On any day that a participant scored greater than 12, he or she would be considered to be experiencing cannabis withdrawal.
[2]
The actual symptom that increased was not noted but was believed to be secondary to cannabis withdrawal.
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
Layout table for Results Point of Contact information
Name/Title: Alan I. Green, M.D.
Organization: Geisel School of Medicine at Dartmouth
Phone: 603-650-7549
EMail: alan.i.green@dartmouth.edu
Layout table for additonal information
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