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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

Tracking Information
First Submitted Date  ICMJE September 12, 2016
First Posted Date  ICMJE September 15, 2016
Results First Submitted Date  ICMJE April 5, 2019
Results First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 28, 2019
Study Start Date  ICMJE February 2013
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
Responses to Negative Stimuli [ Time Frame: 15 minutes during each session ]
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 will follow each picture to collect subjective reactions.
Change History Complete list of historical versions of study NCT02902081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
Emotional Recognition [ Time Frame: 15 minutes during each session ]
Participants complete the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following CBD or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions. In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 "frames" progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to "press the space bar as soon as you know what expression is being displayed." This ended the sequence and presented options of "angry," "fearful," "sad," and "happy." Perception of expressions was quantified as the intensity (0-100 %) of the face when the participant pressed the space bar for correctly identified sequences.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol and Emotional Stimuli
Official Title  ICMJE Effects of Cannabidiol on Responses to Emotional Stimuli
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Drug Addiction
Intervention  ICMJE
  • Drug: Cannabidiol
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Oral placebo administered once prior to subjective drug effects questionnaires and behavioral tasks.
    Intervention: Drug: Placebo
  • Experimental: Cannabidiol
    (300 mg, 600 mg, 900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
    Intervention: Drug: Cannabidiol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2017)
38
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2016)
36
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02902081
Other Study ID Numbers  ICMJE IRB13-0215
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE INSYS Therapeutics Inc
Investigators  ICMJE Not Provided
PRS Account University of Chicago
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP