Clinical trial NCT05407285: A Study of Ingested Cannabidiol in Healthy Occasional Cannabis Users
Official title: A Triple-blind, Placebo-controlled, Randomized, Crossover Study of Low Dose Oral Synthetic Cannabidiol Effects in Healthy Cannabis Occasional Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cannabis
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment In this crossover design, participants will be administered both dosages of CBD and placebo during participation in the study. Participant will be randomly assigned to one of ten pre-determined sequences with a CBD or placebo product at 5 dosages (0 mg, 20 mg, 50 mg, 100 mg and 200 mg). Participants will be randomized based on a completely balanced 5 by 5 latin square.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pleasant drug effect
timeFrame: T1 (60 minutes after ingestion)
measure: Pleasant drug effect
timeFrame: T2 (120 minutes after ingestion)
measure: Pleasant drug effect
timeFrame: T3 (210 minutes after ingestion)
measure: Pleasant drug effect
timeFrame: T4 (300 minutes after ingestion)
measure: Pleasant drug effect
timeFrame: T5 (360 minutes after ingestion)
Secondary outcomes:
measure: Drug Effects associated with cannabis ingestion
timeFrame: T1 (60 minutes after ingestion)
measure: Drug Effects associated with cannabis ingestion
timeFrame: T2 (120 minutes after ingestion)
measure: Drug Effects associated with cannabis ingestion
timeFrame: T3 (210 minutes after ingestion)
measure: Drug Effects associated with cannabis ingestion
timeFrame: T4 (300 minutes after ingestion)
measure: Drug Effects associated with cannabis ingestion
timeFrame: T5 (360 minutes after ingestion)
measure: Change in dissociation
timeFrame: Baseline and after ingestion at (120 minutes, 300 minutes)
measure: Cannabis-Specific Subjective Effects
timeFrame: T5 (360 minutes after ingestion)
measure: Change in Affect
timeFrame: Baseline and after ingestion at (120 minutes, 300 minutes)
measure: Change in Anxiety Symptoms
timeFrame: Baseline and after ingestion at (120 minutes, 300 minutes)
measure: Change in the incidence of Treatment Emergent-adverse Events
timeFrame: Baseline and after ingestion at (60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
measure: Change on cognition
timeFrame: Baseline and after ingestion at 210 minutes
measure: Visit Intoxication Assessment
timeFrame: End of the visit, approximatively 360 minutes after ingestion
Other outcomes:
measure: Change in plasma concentration of CBD
timeFrame: Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
measure: Change in plasma concentration of 7-Hydroxy-cannabidiol
timeFrame: Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
measure: Change in plasma concentration of 7-Carboxy-Cannabidiol
timeFrame: Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
measure: Change in plasma concentration of Anandamide
timeFrame: Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
Locations:
city: Montréal
country: Canada
facility: Centre de recherche du Centre Hospitalier Universitaire de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Didier Jutras-Aswad, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: