NCT05320367

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
15mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
4.4 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

March 20, 2022

Last Update Submit

December 16, 2025

Conditions

Cannabis

Outcome Measures

Primary Outcomes (3)

  • 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).

    T1(10 minutes after inhalation)

  • 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).

    T2 (80 minutes after inhalation)

  • 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).

    T3 (140 minutes after inhalation)

Secondary Outcomes (10)

  • Drug Effects associated with cannabis administration

    T1 (10 minutes after inhalation)

  • Drug Effects associated with cannabis administration

    T2 (80 minutes after inhalation)

  • Drug Effects associated with cannabis administration

    T3 (140 minutes after inhalation)

  • Change in dissociation

    Baseline and after inhalation at (10 minutes, 80 minutes)

  • Cannabis-Specific Subjective Effects

    T3 (140 minutes after inhalation)

  • +5 more secondary outcomes

Other Outcomes (4)

  • Change in plasma concentration of CBD

    Baseline and after inhalation at ( 5 minutes, 15 minutes, 80 minutes, 110 minutes, 140 minutes)

  • Change in plasma concentration of 7-Hydroxycannabidiol

    Baseline and after inhalation at ( 5 minutes, 15 minutes, 80 minutes, 110 minutes, 140 minutes)

  • Change in plasma concentration of 7-Carboxy-Cannabidiol

    Baseline and after inhalation at ( 5 minutes, 15 minutes, 80 minutes, 110 minutes, 140 minutes)

  • +1 more other outcomes

Study Arms (5)

CBD (Group 1)

EXPERIMENTAL

Group will receive four CBD doses (5 mg, 20 mg, 50 mg and 100 mg), and placebo (0 mg). 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

Drug: Cannabis, placebo

CBD (Group 2)

EXPERIMENTAL

Group will receive four CBD doses (5 mg, 20 mg, 50 mg and 100 mg), and placebo (0 mg). 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

Drug: Cannabis, placebo

CBD (Group 3)

EXPERIMENTAL

Group will receive four CBD doses (5 mg, 20 mg, 50 mg and 100 mg), and placebo (0 mg). 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.

Drug: Cannabis, placebo

CBD (Group 4)

EXPERIMENTAL

Group will receive four CBD doses (5 mg, 20 mg, 50 mg and 100 mg), and placebo (0 mg). 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.

Drug: Cannabis, placebo

CBD (Group 5)

EXPERIMENTAL

Group will receive four CBD doses (5 mg, 20 mg, 50 mg and 100 mg), and placebo (0 mg). 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.

Drug: Cannabis, placebo

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.

CBD (Group 1)CBD (Group 2)CBD (Group 3)CBD (Group 4)CBD (Group 5)

Eligibility Criteria

Age21 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 21 and 49 years of age, inclusively;
  • Have used cannabis at least once in lifetime AND have used cannabis three days or less in the 28 days prior to enrollment;
  • Be able to provide a signed informed consent;
  • 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;
  • Have a forced expiratory volume in first second (FEV) sup 90 %;
  • Able to communicate and understand English or French language;
  • 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.

You may not qualify if:

  • 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;
  • 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);
  • 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;
  • Known chronic liver disease or aspartate transaminase/alanine transaminase (AST/ALT) two times higher than upper limit of normal values at screening visit;
  • Blood pressure higher than 130/80 mmHg;
  • Kidney disorders;
  • Bleeding disorders;
  • 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 ;
  • Currently pregnant,breastfeeding or planning to become pregnant either at screening or while enrolled in the study;
  • Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;
  • Use of medication within 7 days of experimental sessions, which, in the opinion of the investigator, may interact with cannabis;
  • Participation in clinical studies or undergoing other investigational procedures involving cannabis or cannabinoids administration within 30 days prior to randomization;
  • Resting heart rate over 100 beats per minute;
  • Current body mass index (BMI) over 29.9 kg/m2;
  • Any clinically significant electrocardiogram abnormalities at screening visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Didier Jutras-Aswad, MD,MS

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Lachance, PhD

CONTACT

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

François-Olivier Hébert, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2022

First Posted

April 11, 2022

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share