Modulation of THC Effects by CBD: a Dose-ranging Study

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are 1) to determine if CBD modulates THC-induced acute psychoactive effects at different CBD:THC ratios, compared with the control product (0:20, 20:20, 40:20, 80:20, 120:20) and 2) to determine if different doses of CBD modulate other THC induced behavioral effects, compared with the control product and 3)To explore qualitatively whether CBD modulates THC effects by mechanisms that are not detected with standard clinical research tools.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Treatments: Cannabidiol; Dronabinol

Criteria

Inclusion Criteria:

1. Between 21 and 49 years of age, inclusively;

2. Have used cannabis at least once in their lifetime and have used cannabis three days or less in the 30 days prior to enrollment;

3. Be able to provide a signed informed consent;

4. Willing to comply with study procedures and requirements as per protocol;

5. Have a forced expiratory volume in first second (FEV) less than or equal to 90 %;

6. Able to communicate and understand English or French language;

7. For female participants:

a. No childbearing potential, defined as: i. postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age); or ii. Documented surgically sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or b. For female of childbearing potential: i. Must have negative pregnancy test result at screening and at subsequent visits.

ii. AND have no pregnancy plan while on the study iii. AND must agree to use a medically accepted method of birth control throughout the study.

Exclusion criteria

Participants will be excluded if any of the following criteria are met:

1. Any disabling medical condition, as assessed by medical history, physical exam, vital signs and/or laboratory assessments that, in the opinion of the study physician, precludes safe participation in the study or the ability to provide fully informed consent;

2. Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current suicidality based on the Mini International Neuropsychiatric Interview);

3. Any other disabling, unstable or acute mental condition that, in the opinion of the study physician, precludes safe participation in the study or ability to provide fully informed consent;

4. Known chronic liver disease or aspartate transaminase/alanine transaminase (AST/ALT) two times higher than upper limit of normal values at screening visit;

5. Blood pressure higher than 130/80 mmHg;

6. Kidney disorders;

7. Bleeding disorders;

8. Current moderate or severe DSM-5 substance use disorder (except nicotine) according to SCID-V;

9. Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;

10. Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;

11. Use of medication within 7 days of experimental sessions; which, in the opinion of the Investigator, may interact with cannabis.

12. Participation in clinical studies or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomization.

13. Resting heart rate over 100 beats per minute.

14. Current body mass index (BMI) over 29.9 kg/m2.

15. Any clinically significant electrocardiogram abnormalities at screening visit.