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Cannabidiol and Emotional Stimuli (CAS)

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ClinicalTrials.gov Identifier: NCT02902081
Recruitment Status : Completed
First Posted : September 15, 2016
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
INSYS Therapeutics Inc
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Drug Addiction
Interventions Drug: Cannabidiol
Drug: Placebo
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ALL Study Participants
Hide Arm/Group Description This is a within-subjects study design in which "all" participants received "all" three does (300, 600, and 900 mg oral) of cannabidol and a placebo in randomized order.
Period Title: Overall Study
Started 38
Completed 38
Not Completed 0
Arm/Group Title ALL Study Participants
Hide Arm/Group Description This is a within-subjects study design in which "all" participants received "all" three does (300, 600, and 900 mg oral) of cannabidol and a placebo in randomized order.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
0
   0.0%
Between 18 and 65 years
38
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
19
  50.0%
Male
19
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Caucasian
22
  57.9%
African-American
10
  26.3%
Other
6
  15.8%
1.Primary Outcome
Title Positivity Ratings of Social Images
Hide Description Using the International Affective Picture System (IAPS; Lang et al. 1999), participants viewed standardized positive, negative and neutral pictures from the IAPS. The negative and positive images were matched on degree of valence and arousal. An Evaluative Space Grid rating followed each picture to collect subjective reactions. Ratings are on a 9-pt scale. The range of the scale is from 1 to 9 (Min score 1, max score 9). The total score is reported. Higher numbers represent more positive valence or greater arousal. Drug treatment: within-subjects; every participant received all drug doses, counter-balanced.
Time Frame End of study (time 0 and approximately 4 weeks later), week 4 reported.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 300 mg Cannabidiol 600 mg Cannabidiol 900 mg Cannabidiol
Hide Arm/Group Description:
Placebo capsule administered once prior to subjective drug effects questionnaires and behavioral tasks.
(300 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
(600 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
(900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
Overall Number of Participants Analyzed 38 38 38 38
Mean (Standard Error)
Unit of Measure: score on a scale
Positive Image 1.96  (0.11) 1.68  (0.13) 1.86  (0.10) 1.93  (0.11)
Negative Image 0.47  (0.07) 0.48  (0.08) 0.41  (0.06) 0.35  (0.06)
Neutral Image 1.12  (0.10) 0.99  (0.10) 1.08  (0.08) 1.13  (0.10)
Time Frame .Through study completion, an average of 5 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Cannabidiol
Hide Arm/Group Description

Oral placebo administered once prior to subjective drug effects questionnaires and behavioral tasks.

Placebo

(300 mg, 600 mg, 900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
All-Cause Mortality
Placebo Cannabidiol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Cannabidiol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Cannabidiol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Harriet de Wit
Organization: University of Chicago
Phone: 7737023560
EMail: dewitlab@yoda.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02902081     History of Changes
Other Study ID Numbers: IRB13-0215
First Submitted: September 12, 2016
First Posted: September 15, 2016
Results First Submitted: April 5, 2019
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019