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The Effects of Cannabis Use in People With Schizophrenia on Clinical, Neuropsychological and Physiological Phenotypes

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ClinicalTrials.gov Identifier: NCT01832766
Recruitment Status : Terminated (Unable to find subjects with schizophrenia that were using only cannabis)
First Posted : April 16, 2013
Results First Posted : September 21, 2015
Last Update Posted : September 21, 2015
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition Schizophrenia
Interventions Drug: Dronabinol
Other: Placebo Comparator
Enrollment 13
Recruitment Details Age-eligible participants were recruited from May 2005 to May 2010 and were recruited from local mental health centers.
Pre-assignment Details 14 recruited; 14 screened: 1 excluded (did not meet inclusion criteria)
Arm/Group Title Dronabinol 10 mg First Then Placebo Placebo First Then 10 mg Dronabinol
Hide Arm/Group Description dronabinol 10 mg given oral one dose in first intervention period then 1 week washout period and then placebo given oral in one dose in second intervention period identical capsule given orally once in first intervention period then 1 week washout period then dronabinol 10 mg given orally once in second intervention period
Period Title: First Intervention
Started 7 6
Completed 7 6 [1]
Not Completed 0 0
[1]
one participant did not return for cross over visit
Period Title: Washout
Started 7 6
Completed 7 5
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Period Title: Second Intervention
Started 7 5
Completed 7 5
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description includes groups randomized to receive placebo first or dronabinol 10 mg first
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
32  (11.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
3
  23.1%
Male
10
  76.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title P50 Auditory Evoked Potential
Hide Description electrophysiological measure of ability to filter extraneous stimuli measured as the amplitude of the evoked response to the second auditory stimulus divided by the amplitude of the evoked response to the first auditory stimulus in mV.
Time Frame 2 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not complete the treatment or the placebo arm (crossover study design).
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
dronabinol 10 mg given oral one dose
identical capsule given once
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: test to conditioning ratio
.62  (.69) .52  (.43)
2.Secondary Outcome
Title California Verbal Learning Test Change at 2 Hours From Baseline
Hide Description ability to remember a list of words given 5 trials. Number of words remembered is normalized to a schizophrenia population and average scores are calculated with age correction. The normal T-score is 50 and scores greater than 50 correspond with greater ability to remember words as compared to a schizophrenia population norm.
Time Frame 2 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not complete the treatment or the placebo arm (crossover study design).
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
dronabinol 10 mg given oral one dose
identical capsule given once
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: T scores
-.5  (1.92) -.77  (1.19)
3.Other Pre-specified Outcome
Title Brief Psychiatric Rating Scale Change From Baseline at 1 Hour
Hide Description Measures psychiatric symptoms. Each item is scored from 1-7. Positive symptoms are calculated from sum of scores on hallucinatory behavior, unusual thought content and conceptual disorganization. Thus, the range of Total Positive Symptoms can be from a score of 3-21 .The higher the score, the more severe the symptom. Negative symptoms have been calculated from sum of blunted affect, emotional withdrawal and motor retardation. The range of Total Negative Symptoms can be from a score of 3-21. The higher the score, the more severe the symptoms. As this is a difference from baseline, there can be either negative or positive results as the subjects can either be better than baseline (positive score) or worse than baseline (negative score).
Time Frame at 1 hour after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not complete the treatment or the placebo arm (crossover study design).
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
dronabinol 10 mg given oral one dose
identical capsule given once
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.73  (1.1) 3.18  (.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description dronabinol 10 mg given oral one dose identical capsule given once
All-Cause Mortality
Dronabinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dronabinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dronabinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
early termination as recruitment of subjects with only cannabis use was difficult leading to small number of subjects analyzed
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: Lynn Johnson, Pharm.D.
Organization: University of Colorado Denver
Phone: 303 724 6221
EMail: lynn.johnson@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01832766     History of Changes
Other Study ID Numbers: 05-0359
First Submitted: March 25, 2013
First Posted: April 16, 2013
Results First Submitted: June 30, 2014
Results First Posted: September 21, 2015
Last Update Posted: September 21, 2015