Drug Addiction
Conditions
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.
Interventions
DRUGCannabidiol
DRUGPlacebo
Sponsors
INSYS Therapeutics Inc
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | ALL Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Race/Ethnicity, Customized African-American | 10 Participants |
| Race/Ethnicity, Customized Caucasian | 22 Participants |
| Race/Ethnicity, Customized Other | 6 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
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.
Time frame: End of study (time 0 and approximately 4 weeks later), week 4 reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Positivity Ratings of Social Images | Positive Image | 1.96 score on a scale | Standard Error 0.11 |
| Placebo | Positivity Ratings of Social Images | Neutral Image | 1.12 score on a scale | Standard Error 0.1 |
| Placebo | Positivity Ratings of Social Images | Negative Image | 0.47 score on a scale | Standard Error 0.07 |
| 300 mg Cannabidiol | Positivity Ratings of Social Images | Positive Image | 1.68 score on a scale | Standard Error 0.13 |
| 300 mg Cannabidiol | Positivity Ratings of Social Images | Neutral Image | 0.99 score on a scale | Standard Error 0.1 |
| 300 mg Cannabidiol | Positivity Ratings of Social Images | Negative Image | 0.48 score on a scale | Standard Error 0.08 |
| 600 mg Cannabidiol | Positivity Ratings of Social Images | Negative Image | 0.41 score on a scale | Standard Error 0.06 |
| 600 mg Cannabidiol | Positivity Ratings of Social Images | Positive Image | 1.86 score on a scale | Standard Error 0.1 |
| 600 mg Cannabidiol | Positivity Ratings of Social Images | Neutral Image | 1.08 score on a scale | Standard Error 0.08 |
| 900 mg Cannabidiol | Positivity Ratings of Social Images | Positive Image | 1.93 score on a scale | Standard Error 0.11 |
| 900 mg Cannabidiol | Positivity Ratings of Social Images | Neutral Image | 1.13 score on a scale | Standard Error 0.1 |
| 900 mg Cannabidiol | Positivity Ratings of Social Images | Negative Image | 0.35 score on a scale | Standard Error 0.06 |