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Trial Outcomes & Findings for Cannabidiol and Emotional Stimuli (NCT NCT02902081)

NCT ID: NCT02902081

Last Updated: 2019-08-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

End of study (time 0 and approximately 4 weeks later), week 4 reported.

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure
ALL Study Participants
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 Study
STARTED
38
Overall Study
COMPLETED
38
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cannabidiol and Emotional Stimuli

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ALL Study Participants
n=38 Participants
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.
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
38 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Sex: Female, Male
Female
19 Participants
n=93 Participants
Sex: Female, Male
Male
19 Participants
n=93 Participants
Race/Ethnicity, Customized
Caucasian
22 Participants
n=93 Participants
Race/Ethnicity, Customized
African-American
10 Participants
n=93 Participants
Race/Ethnicity, Customized
Other
6 Participants
n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo
n=38 Participants
Placebo capsule administered once prior to subjective drug effects questionnaires and behavioral tasks.
300 mg Cannabidiol
n=38 Participants
(300 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
600 mg Cannabidiol
n=38 Participants
(600 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
900 mg Cannabidiol
n=38 Participants
(900 mg) cannabidiol administered once prior to subjective drug effects questionnaires and behavioral tasks.
Positivity Ratings of Social Images
Positive Image
1.96 score on a scale
Standard Error 0.11
1.68 score on a scale
Standard Error 0.13
1.86 score on a scale
Standard Error 0.10
1.93 score on a scale
Standard Error 0.11
Positivity Ratings of Social Images
Negative Image
0.47 score on a scale
Standard Error 0.07
0.48 score on a scale
Standard Error 0.08
0.41 score on a scale
Standard Error 0.06
0.35 score on a scale
Standard Error 0.06
Positivity Ratings of Social Images
Neutral Image
1.12 score on a scale
Standard Error 0.10
0.99 score on a scale
Standard Error 0.10
1.08 score on a scale
Standard Error 0.08
1.13 score on a scale
Standard Error 0.10

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cannabidiol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Harriet de Wit

University of Chicago

Phone: 7737023560

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place