CAS: Cannabidiol and Emotional Stimuli

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT02902081
• Collaborator: INSYS Therapeutics Inc (Industry)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 48.9
• Patients Per Site Per Month: 0.8

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Feb 1, 2013
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 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 [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

Criteria

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

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

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• INSYS Therapeutics Inc

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 11, 2016

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT02902081
• Other Study ID Numbers: IRB13-0215
• First Posted: Sep 15, 2016
• Last Update Posted: Aug 28, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Substance-Related Disorders; Cannabidiol

Study Results

Participant Flow

Arm/Group Title	ALL Study Participants
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

Baseline Characteristics

Arm/Group Title	ALL Study Participants
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 Participants	38
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	38 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	19 50%
Male	19 50%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	22 57.9%
African-American	10 26.3%
Other	6 15.8%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	300 mg Cannabidiol	600 mg Cannabidiol	900 mg Cannabidiol
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.
Measure Participants	38	38	38	38
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)

Adverse Events

Time Frame	.Through study completion, an average of 5 weeks.
Arm/Group Title	Placebo		Cannabidiol
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/38 (0%)
Serious Adverse Events
	Placebo		Cannabidiol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Cannabidiol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/38 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.