Back to resultsCannabidiol and Emotional Stimuli (CAS)
Primary Purpose
Drug Addiction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Drug Addiction
Eligibility Criteria
Inclusion Criteria:
- 18-35 years of age.
- 38 healthy volunteers (19 male, 19 female; age range 18-35 years)
- All participants recruited without regard to race, religion or ethnicity through posters, advertisements and word-of-mouth referrals.
- Candidates screened in accordance with our general screening protocol, approved by the IRB under Protocol #13681B, which includes a physical, EKG, psychiatric screening interview and detailed drug use history questionnaire.
Exclusion Criteria:
- Individuals with a medical condition contraindicating study participation, as determined by the study site physician.
- Individuals regularly using any medications aside from hormonal contraception in women.
- Individuals with a current (active in the past year) DSM-IV Axis I mood, anxiety, eating, or substance dependence disorder or a lifetime history of a psychotic disorder or mania.
- Women who are pregnant, nursing, or planning to become pregnant in the next 3 months
- Participants reporting a known or suspected allergy to cannabinoids.
- The self-report questionnaires the investigators use require fluency in English, and have not been translated and validated in other languages, thus individuals with less than a high-school education or those not fluent in English were excluded, as lack of English familiarity at a high school level may compromise our ability to interpret their self-reports.
- Individuals with a BMI below 19 or above 30, as this would change dosing requirements.
- Individuals who report using marijuana >100 times in their lifetime, to reduce variation in possible developed tolerance to CBD.
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Cannabidiol
Arm Description
Oral placebo administered once prior to subjective drug effects questionnaires and behavioral tasks.
(300 mg, 600 mg, 900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
Outcomes
Primary Outcome Measures
Positivity Ratings of Social Images
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02902081
First Posted
September 12, 2016
Last Updated
August 26, 2019
Sponsor
University of Chicago
Collaborators
INSYS Therapeutics Inc
1. Study Identification
Unique Protocol Identification Number
NCT02902081
Brief Title
Cannabidiol and Emotional Stimuli
Acronym
CAS
Official Title
Effects of Cannabidiol on Responses to Emotional Stimuli
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
INSYS Therapeutics Inc
4. Oversight
5. Study Description
Brief Summary
The purpose of this research is to examine the effect of cannabidiol (CBD), a cannabinoid compound found in marijuana, on responses to emotional stimuli. Both preclinical and clinical studies indicate that CBD may act to reduce anxiety without excessive sedative side-effects. Thus the investigators hypothesize that CBD may reduce responses specifically to negative emotional and social stimuli, including pictures and emotional faces, without altering responses to positive stimuli. To examine this, the investigators will administer placebo, 300mg, 600mg, and 900mg CBD to healthy normal adults in a double-blind within-subjects study. The investigators will measure subjective and subtle physical responses to positive and negative stimuli using measures that have been characterized with classic anxiety-reducing drugs and drugs of abuse. Further, the investigators will examine whether CBD-induced changes in these measures of emotional response relate to changes in actual behavior in a controlled social interaction. These results will allow the investigators to examine the potential usefulness of CBD as an anxiety-reducing drug, and suggest mechanisms by which CBD may reduce anxiety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Addiction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo administered once prior to subjective drug effects questionnaires and behavioral tasks.
Arm Title
Cannabidiol
Arm Type
Experimental
Arm Description
(300 mg, 600 mg, 900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Positivity Ratings of Social Images
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-35 years of age.
38 healthy volunteers (19 male, 19 female; age range 18-35 years)
All participants recruited without regard to race, religion or ethnicity through posters, advertisements and word-of-mouth referrals.
Candidates screened in accordance with our general screening protocol, approved by the IRB under Protocol #13681B, which includes a physical, EKG, psychiatric screening interview and detailed drug use history questionnaire.
Exclusion Criteria:
Individuals with a medical condition contraindicating study participation, as determined by the study site physician.
Individuals regularly using any medications aside from hormonal contraception in women.
Individuals with a current (active in the past year) DSM-IV Axis I mood, anxiety, eating, or substance dependence disorder or a lifetime history of a psychotic disorder or mania.
Women who are pregnant, nursing, or planning to become pregnant in the next 3 months
Participants reporting a known or suspected allergy to cannabinoids.
The self-report questionnaires the investigators use require fluency in English, and have not been translated and validated in other languages, thus individuals with less than a high-school education or those not fluent in English were excluded, as lack of English familiarity at a high school level may compromise our ability to interpret their self-reports.
Individuals with a BMI below 19 or above 30, as this would change dosing requirements.
Individuals who report using marijuana >100 times in their lifetime, to reduce variation in possible developed tolerance to CBD.
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cannabidiol and Emotional Stimuli
We'll reach out to this number within 24 hrs