A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users

Phase 2Not Yet RecruitingNCT05320367

Centre hospitalier de l'Université de Montréal (CHUM)80 enrolled

Overview

The purposes of this study are 1) to determine if the administration of different low doses of CBD (5 mg, 20 mg, 50 mg and 100 mg) result in detectable subjective pleasant drug effect compared to placebo and 2) to qualitatively explore whether low dose CBD is associated with effects that are not detected with the available research tools.

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 CBD (between 5-100mg) and placebo in occasional cannabis users. Potential outcomes not detected with usual assessment tools designed to evaluate THC-induced effects will also be explored.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cannabis

Interventions

Cannabis, placeboDRUG

Eligible participant will be randomize 1:1:1:1:1 to receive placebo, CBD (5mg, 20mg, 50mg and 100mg). Only one research product will be inhaled for each visit. The sequence will depend on the assigned randomization group.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Between 21 and 49 years of age, inclusively; 2. Have used cannabis at least once in lifetime AND have 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. Have a forced expiratory volume in first second (FEV) sup 90 %; 6. Able to communicate and understand English or French language; 7. 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 must agree to use a medically accepted method of birth control throughout the study. Exclusion Criteria: 1. Any disabling medical conditions, 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 (e.g. history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current suicidality, acute depression or anxiety disorder 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 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 (The Diagnostic and Statistical Manual of Mental Disorders) substance use disorder (except nicotine) according to the Structured Clinical Interview for DSM-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 procedures 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.

Outcomes

Primary Outcomes

Pleasant drug effect

Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).

Time frame: T1(10 minutes after inhalation)

Pleasant drug effect

Time frame: T2 (80 minutes after inhalation)

Pleasant drug effect

Time frame: T3 (140 minutes after inhalation)

Secondary Outcomes

Drug Effects associated with cannabis administration

Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).

Time frame: T1 (10 minutes after inhalation)

Drug Effects associated with cannabis administration

Time frame: T2 (80 minutes after inhalation)

Central Contacts

Pamela Lachance, PhD

CONTACT

514-890-8000 pamela.lachance-touchette.chum@ssss.gouv.qc.ca

François-Olivier Hébert, PhD

CONTACT

581-741-4941 francois-olivier.hebert.chum@ssss.gouv.qc.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.