Clinical trial NCT05320367: A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
Official title: A Randomized, Triple Blinded Cross-over Placebo Controlled Study of Effects of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cannabis
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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, 5 mg, 20 mg, 50 mg and 100 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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pleasant drug effect
timeFrame: T1(10 minutes after inhalation)
measure: Pleasant drug effect
timeFrame: T2 (80 minutes after inhalation)
measure: Pleasant drug effect
timeFrame: T3 (140 minutes after inhalation)
Secondary outcomes:
measure: Drug Effects associated with cannabis administration
timeFrame: T1 (10 minutes after inhalation)
measure: Drug Effects associated with cannabis administration
timeFrame: T2 (80 minutes after inhalation)
measure: Drug Effects associated with cannabis administration
timeFrame: T3 (140 minutes after inhalation)
measure: Change in dissociation
timeFrame: Baseline and after inhalation at (10 minutes, 80 minutes)
measure: Cannabis-Specific Subjective Effects
timeFrame: T3 (140 minutes after inhalation)
measure: Change in Affect
timeFrame: Baseline and after inhalation at (10 minutes, 80 minutes, 140 minutes)
measure: Change in Anxiety Symptoms
timeFrame: Baseline and after inhalation at (10 minutes, 80 minutes and 140 minutes)
measure: Change in Safety
timeFrame: Baseline and after inhalation at (10 minutes, 80 minutes, 140 minutes)
measure: Change on cognition
timeFrame: Baseline and after inhalation at T2 (80 minutes).
measure: Visit Intoxication Assessment
timeFrame: End of the visit, approximatively 180 minutes after inhalation
Other outcomes:
measure: Change in plasma concentration of CBD
timeFrame: Baseline and after inhalation at ( 5 minutes, 15 minutes, 80 minutes, 110 minutes, 140 minutes)
measure: Change in plasma concentration of 7-Hydroxycannabidiol
timeFrame: Baseline and after inhalation at ( 5 minutes, 15 minutes, 80 minutes, 110 minutes, 140 minutes)
measure: Change in plasma concentration of 7-Carboxy-Cannabidiol
timeFrame: Baseline and after inhalation at ( 5 minutes, 15 minutes, 80 minutes, 110 minutes, 140 minutes)
measure: Change in plasma concentration of Anandamide
timeFrame: Baseline and after inhalation at ( 5 minutes, 15 minutes, 80 minutes, 110 minutes, 140 minutes)
Locations:
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Didier Jutras-Aswad, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: