NCT05407285

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 22, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

June 2, 2022

Last Update Submit

April 19, 2024

Conditions

Cannabis

Outcome Measures

Primary Outcomes (5)

  • 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 (60 minutes after ingestion)

  • 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 (120 minutes after ingestion)

  • 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 (210 minutes after ingestion)

  • 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).

    T4 (300 minutes after ingestion)

  • 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).

    T5 (360 minutes after ingestion)

Secondary Outcomes (12)

  • Drug Effects associated with cannabis ingestion

    T1 (60 minutes after ingestion)

  • Drug Effects associated with cannabis ingestion

    T2 (120 minutes after ingestion)

  • Drug Effects associated with cannabis ingestion

    T3 (210 minutes after ingestion)

  • Drug Effects associated with cannabis ingestion

    T4 (300 minutes after ingestion)

  • Drug Effects associated with cannabis ingestion

    T5 (360 minutes after ingestion)

  • +7 more secondary outcomes

Other Outcomes (4)

  • Change in plasma concentration of CBD

    Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)

  • Change in plasma concentration of 7-Hydroxy-cannabidiol

    Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)

  • Change in plasma concentration of 7-Carboxy-Cannabidiol

    Baseline and after ingestion at ( 60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)

  • +1 more other outcomes

Study Arms (5)

0 mg CBD, ingested placebo

EXPERIMENTAL

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.

Drug: cannabis 0 mg, placeboDrug: Cannabis 20 mg,Drug: Cannabis 50 mgDrug: Cannabis 100 mgDrug: Cannabis 200 mg

20 mg CBD, ingested CBD

EXPERIMENTAL

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.

Drug: cannabis 0 mg, placeboDrug: Cannabis 20 mg,Drug: Cannabis 50 mgDrug: Cannabis 100 mgDrug: Cannabis 200 mg

50 mg CBD, ingested CBD

EXPERIMENTAL

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.

Drug: cannabis 0 mg, placeboDrug: Cannabis 20 mg,Drug: Cannabis 50 mgDrug: Cannabis 100 mgDrug: Cannabis 200 mg

100 mg CBD, ingested CBD

EXPERIMENTAL

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.

Drug: cannabis 0 mg, placeboDrug: Cannabis 20 mg,Drug: Cannabis 50 mgDrug: Cannabis 100 mgDrug: Cannabis 200 mg

200 mg CBD, ingested CBD

EXPERIMENTAL

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.

Drug: cannabis 0 mg, placeboDrug: Cannabis 20 mg,Drug: Cannabis 50 mgDrug: Cannabis 100 mgDrug: Cannabis 200 mg

Interventions

cannabis 0 mg, placeboDRUG

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.

Also known as: CBD, placebo
0 mg CBD, ingested placebo100 mg CBD, ingested CBD20 mg CBD, ingested CBD200 mg CBD, ingested CBD50 mg CBD, ingested CBD
Cannabis 20 mg,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.

Also known as: CBD
0 mg CBD, ingested placebo100 mg CBD, ingested CBD20 mg CBD, ingested CBD200 mg CBD, ingested CBD50 mg CBD, ingested CBD
Cannabis 50 mgDRUG

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.

Also known as: CBD
0 mg CBD, ingested placebo100 mg CBD, ingested CBD20 mg CBD, ingested CBD200 mg CBD, ingested CBD50 mg CBD, ingested CBD
Cannabis 100 mgDRUG

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.

Also known as: CBD
0 mg CBD, ingested placebo100 mg CBD, ingested CBD20 mg CBD, ingested CBD200 mg CBD, ingested CBD50 mg CBD, ingested CBD
Cannabis 200 mgDRUG

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.

Also known as: CBD
0 mg CBD, ingested placebo100 mg CBD, ingested CBD20 mg CBD, ingested CBD200 mg CBD, ingested CBD50 mg CBD, ingested CBD

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 21 and 65 years of age, inclusively;
  • Occasional users, having 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;
  • 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 agree to use a medically accepted method of birth control throughout the study.

You may not qualify if:

  • 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;
  • Known chronic liver disease or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>ULN (Upper Limit of Normal) at screening visit;
  • Mean systolic blood pressure \>180 mmHg (millimeter of mercury);
  • Resting heart rate over 100 beats per minute (bpm);
  • Current body mass index (BMI) of over 40;
  • Must not have any clinically significant ECG abnormalities at screening visit;
  • 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);
  • 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;
  • Current substance use disorder (except nicotine) according to Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders ( SCID-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 CBD,
  • Participation in clinical trials or undergoing other investigational procedure related to cannabis or cannabinoid administration within 30 days prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche du Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, H2X0A9, Canada

Location

Related Publications (1)

  • Abboud A, Chester LA, Hebert FO, Jutras-Aswad D. Sex-specific association between low oral doses of cannabidiol (CBD) and plasma concentration of anandamide (AEA), N-palmitoylethanolamine (PEA) and N-oleoylethanolamine (OEA) in healthy occasional cannabis users. J Cannabis Res. 2026 Jan 9. doi: 10.1186/s42238-025-00356-x. Online ahead of print.

    PMID: 41514385DERIVED

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

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: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

July 22, 2022

Primary Completion

November 14, 2023

Study Completion

November 14, 2023

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)