A Study of Ingested Cannabidiol in Healthy Occasional Cannabis Users

NCT ID: NCT05407285

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-22
• Study Completion Date: 2023-11-14

Brief Summary

The purposes of this study are 1) to determine if the administration of different low doses of oral CBD (20 mg, 50 mg, 100 mg and 200 mg) result in detectable subjective pleasant drug effect compared to placebo and 2) to qualitatively explore whether low dose of oral CBD is associated with effects that are not detected with the available research tools.

Detailed Description

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.

Conditions

Cannabis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0 mg CBD, ingested placebo

Ingested placebo containing 0 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.

Group Type: EXPERIMENTAL

cannabis 0 mg, placebo

Intervention Type: DRUG

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.

Cannabis 20 mg,

Intervention Type: DRUG

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.

Cannabis 50 mg

Intervention Type: DRUG

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.

Cannabis 100 mg

Intervention Type: DRUG

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.

Cannabis 200 mg

Intervention Type: DRUG

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.

20 mg CBD, ingested CBD

Ingested cannabis containing 20 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.

Group Type: EXPERIMENTAL

cannabis 0 mg, placebo

Intervention Type: DRUG

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.

Cannabis 20 mg,

Intervention Type: DRUG

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.

Cannabis 50 mg

Intervention Type: DRUG

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.

Cannabis 100 mg

Intervention Type: DRUG

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.

Cannabis 200 mg

Intervention Type: DRUG

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.

50 mg CBD, ingested CBD

Ingested cannabis containing 50 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.

Group Type: EXPERIMENTAL

cannabis 0 mg, placebo

Intervention Type: DRUG

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.

Cannabis 20 mg,

Intervention Type: DRUG

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.

Cannabis 50 mg

Intervention Type: DRUG

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.

Cannabis 100 mg

Intervention Type: DRUG

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.

Cannabis 200 mg

Intervention Type: DRUG

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.

100 mg CBD, ingested CBD

Ingested cannabis containing 100 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.

Group Type: EXPERIMENTAL

cannabis 0 mg, placebo

Intervention Type: DRUG

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.

Cannabis 20 mg,

Intervention Type: DRUG

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.

Cannabis 50 mg

Intervention Type: DRUG

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.

Cannabis 100 mg

Intervention Type: DRUG

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.

Cannabis 200 mg

Intervention Type: DRUG

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.

200 mg CBD, ingested CBD

Ingested cannabis containing 200 mg CBD Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.

Group Type: EXPERIMENTAL

cannabis 0 mg, placebo

Intervention Type: DRUG

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.

Cannabis 20 mg,

Intervention Type: DRUG

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.

Cannabis 50 mg

Intervention Type: DRUG

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.

Cannabis 100 mg

Intervention Type: DRUG

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.

Cannabis 200 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

CBD, placebo; CBD; CBD; CBD; CBD

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier Jutras-Aswad, MD,MS

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre de recherche du Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

22.049

Identifier Type: -

Identifier Source: org_study_id