A Triple-blind, Placebo-controlled, Randomized, Crossover Study of Low Dose Oral Synthetic Cannabidiol Effects in Healthy Cannabis Occasional Users

Registry facts

Study at a glance

Phase: PHASE1, PHASE2
Enrollment: 70 (ACTUAL)
Start date: 2022-07-22
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Design: RANDOMIZED · CROSSOVER · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

Cannabis contains over 100 cannabinoids, the two most prominent being Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A growing body of evidence exists surrounding the effects of both THC and CBD, however, less is known about the specific effects of CBD concentrations alone. Most existing data regarding the effects of CBD come from studies where this compound is administered in high doses in a therapeutic context, and where the subject can be administered either CBD, THC or both together. These contexts are not representative of the current use by many consumers. Indeed, several available products contain CBD at much lower doses. The overall objective of this study is to evaluate the acute behavioral and biological effects of low doses of ingested CBD (between 20-200mg) and placebo in occasional cannabis users. Potential outcomes not detected with usual assessment tools designed to evaluate THC-induced effects will also be explored.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

cannabidiol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

cannabis 0 mg, placebo

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

CBD, placebo

DRUG

Cannabis 20 mg,

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

CBD

DRUG

Cannabis 50 mg

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

CBD

DRUG

Cannabis 100 mg

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

CBD

DRUG

Cannabis 200 mg

Eligible participant will be randomize 1:1:1:1:1 to receive study products in a prefilled single syringe with 2 ml of product solution with varying amounts of CBD (0 - 20 mg - 50 mg -100 mg - 200 mg. Only one research product will be ingested at each visit. The sequence will depend on the assigned randomization group.

CBD

Eligibility

Population and criteria

Sex: ALL
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepted

Inclusion criteria

1. Between 21 and 65 years of age, inclusively; 2. Occasional users, having used cannabis three days or less in the 28 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, including to abstain from using other cannabis products or any drugs (except alcohol or nicotine) 7 days prior to study visits; 5. Able to communicate and understand English or French language; 6. For female participants: a. Without 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. With childbearing potential: i. Must have negative pregnancy test result at screening and at subsequent visits. ii. AND have no pregnancy plan while on the trial. iii. AND agree to use a medically accepted method of birth control throughout the study.

Exclusion criteria

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. Known chronic liver disease or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>ULN (Upper Limit of Normal) at screening visit; 3. Mean systolic blood pressure \>180 mmHg (millimeter of mercury); 4. Resting heart rate over 100 beats per minute (bpm); 5. Current body mass index (BMI) of over 40; 6. Must not have any clinically significant ECG abnormalities at screening visit; 7. 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); 8. 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; 9. Current substance use disorder (except nicotine) according to Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders ( SCID-V); 10. Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study; 11. Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion; 12. Use of medication within 7 days of experimental sessions; which, in the opinion of the Investigator, may interact with CBD, 13. Participation in clinical trials or undergoing other investigational procedure related to cannabis or cannabinoid administration within 30 days prior to randomization.

primary outcomes