Cannabidiol and Emotional Stimuli (CAS)

• 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: University of Chicago
• Collaborator: INSYS Therapeutics Inc
• Information provided by (Responsible Party): University of Chicago

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.

Condition or disease	Intervention/treatment	Phase
Drug Addiction	Drug: Cannabidiol; Drug: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effects of Cannabidiol on Responses to Emotional Stimuli
• Study Start Date: February 2013
• Actual Primary Completion Date: March 2017
• Actual Study Completion Date: March 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Oral placebo administered once prior to subjective drug effects questionnaires and behavioral tasks.	Drug: Placebo
Experimental: Cannabidiol; (300 mg, 600 mg, 900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.	Drug: Cannabidiol

Outcome Measures

Primary Outcome Measures :

1. Positivity Ratings of Social Images [ Time Frame: End of study (time 0 and approximately 4 weeks later), week 4 reported. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

INSYS Therapeutics Inc

  Study Documents (Full-Text)

Documents provided by University of Chicago:

Study Protocol and Statistical Analysis Plan  [PDF] May 11, 2016

More Information

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT02902081
• Other Study ID Numbers: IRB13-0215
• First Posted: September 15, 2016
• Results First Posted: August 28, 2019
• Last Update Posted: August 28, 2019
• Last Verified: April 2019

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Cannabidiol; Anticonvulsants