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

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different amounts of CBD (a compound found in cannabis) can affect the psychoactive effects of THC (the compound that makes people feel "high"). The researchers want to see if taking CBD along with THC can change how people feel when they use THC, and if different ratios of CBD to THC make a difference. They will also look at other behavior changes caused by THC to see if CBD influences those too.

To participate in this study, you need to be between 21 and 49 years old, have used cannabis at least once in your life, and not have used it more than three times in the month before joining. You should be able to understand English or French and agree to follow the study's rules. Before enrolling, you will have some health checks to make sure it’s safe for you to participate. If you decide to join, you'll be asked to use specific cannabis products and share your experiences with the researchers, helping them understand how CBD and THC work together.

Gender

ALL

Eligibility 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.