Trial Outcomes & Findings for The Effects of Cannabis Use in People With Schizophrenia on Clinical, Neuropsychological and Physiological Phenotypes (NCT NCT01832766)

Last Updated: 2015-09-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

2 hours after drug administration

Results posted on

2015-09-21

Participant Flow

Age-eligible participants were recruited from May 2005 to May 2010 and were recruited from local mental health centers.

14 recruited; 14 screened: 1 excluded (did not meet inclusion criteria)

Participant milestones

Participant milestones
Measure	Dronabinol 10 mg First Then Placebo 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	Placebo First Then 10 mg Dronabinol 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
First Intervention STARTED	7	6
First Intervention COMPLETED	7	6
First Intervention NOT COMPLETED	0	0
Washout STARTED	7	6
Washout COMPLETED	7	5
Washout NOT COMPLETED	0	1
Second Intervention STARTED	7	5
Second Intervention COMPLETED	7	5
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dronabinol 10 mg First Then Placebo 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	Placebo First Then 10 mg Dronabinol 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
Washout Lost to Follow-up	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=13 Participants includes groups randomized to receive placebo first or dronabinol 10 mg first
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32 years STANDARD_DEVIATION 11.04 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours after drug administration

Population: One participant did not complete the treatment or the placebo arm (crossover study design).

Outcome measures

Outcome measures
Measure	Dronabinol n=12 Participants dronabinol 10 mg given oral one dose	Placebo n=12 Participants identical capsule given once
P50 Auditory Evoked Potential	.62 test to conditioning ratio Standard Deviation .69	.52 test to conditioning ratio Standard Deviation .43

SECONDARY outcome

Timeframe: 2 hours after drug administration

Population: One participant did not complete the treatment or the placebo arm (crossover study design).

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.

Outcome measures

Outcome measures
Measure	Dronabinol n=12 Participants dronabinol 10 mg given oral one dose	Placebo n=12 Participants identical capsule given once
California Verbal Learning Test Change at 2 Hours From Baseline	-.5 T scores Standard Deviation 1.92	-.77 T scores Standard Deviation 1.19

OTHER_PRE_SPECIFIED outcome

Timeframe: at 1 hour after drug administration

Population: One participant did not complete the treatment or the placebo arm (crossover study design).

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).

Outcome measures

Outcome measures
Measure	Dronabinol n=12 Participants dronabinol 10 mg given oral one dose	Placebo n=12 Participants identical capsule given once
Brief Psychiatric Rating Scale Change From Baseline at 1 Hour	3.73 units on a scale Standard Deviation 1.1	3.18 units on a scale Standard Deviation .6

Adverse Events

Dronabinol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lynn Johnson, Pharm.D.

University of Colorado Denver

Phone: 303 724 6221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place