CannabisPhase 1/2NCT05407285

A Study of Ingested Cannabidiol in Healthy Occasional Cannabis Users

A Phase 1/2 study testing Cannabis 20 mg,, Cannabis 50 mg and Cannabis 100 mg in people with Cannabis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cannabis
What is being tested?: Cannabis 20 mg,, Cannabis 50 mg and Cannabis 100 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteCanada
Study dates: 22 Jul 2022to 14 Nov 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:
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.
AND have no pregnancy plan while on the trial. iii. AND agree to use a medically accepted method of birth control throughout the study.

Who cannot join

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;

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre de recherche du Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, H2X0A9

Other trials in Canada

About this study

Official title: A Triple-blind, Placebo-controlled, Randomized, Crossover Study of Low Dose Oral Synthetic Cannabidiol Effects in Healthy Cannabis Occasional Users

Read the 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.

Conditions: Cannabis
Being tested: cannabis 0 mg, placebo, Cannabis 20 mg,, Cannabis 50 mg, Cannabis 100 mg, Cannabis 200 mg
Medical subject headings: Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cannabis 0 mg, placeboDrug
Also called CBD, placebo
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.
Cannabis 20 mg,Drug
Also called CBD
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.
Cannabis 50 mgDrug
Also called CBD
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.
Cannabis 100 mgDrug
Also called CBD
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.
Cannabis 200 mgDrug
Also called CBD
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.

Study groups in NCT05407285
Study group	Role	What they receive
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. Receives: Drug: cannabis 0 mg, placebo; Drug: Cannabis 20 mg,; Drug: Cannabis 50 mg; Drug: Cannabis 100 mg; Drug: 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. Receives: Drug: cannabis 0 mg, placebo; Drug: Cannabis 20 mg,; Drug: Cannabis 50 mg; Drug: Cannabis 100 mg; Drug: 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. Receives: Drug: cannabis 0 mg, placebo; Drug: Cannabis 20 mg,; Drug: Cannabis 50 mg; Drug: Cannabis 100 mg; Drug: 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. Receives: Drug: cannabis 0 mg, placebo; Drug: Cannabis 20 mg,; Drug: Cannabis 50 mg; Drug: Cannabis 100 mg; Drug: 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. Receives: Drug: cannabis 0 mg, placebo; Drug: Cannabis 20 mg,; Drug: Cannabis 50 mg; Drug: Cannabis 100 mg; Drug: Cannabis 200 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: T5 (360 minutes after ingestion)

Secondary outcomes (12)

Drug Effects associated with cannabis ingestion
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Measured: T1 (60 minutes after ingestion)
Drug Effects associated with cannabis ingestion
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Measured: T2 (120 minutes after ingestion)
Drug Effects associated with cannabis ingestion
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Measured: T3 (210 minutes after ingestion)
Drug Effects associated with cannabis ingestion
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Measured: T4 (300 minutes after ingestion)
Drug Effects associated with cannabis ingestion
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis ingestion and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Measured: T5 (360 minutes after ingestion)
Change in dissociation
Dissociation will be assessed using the Clinician Administered Dissociative States Scale administered at Baseline (T0) and following administration of the study product (T2- 120 minutes, T4-300 minutes) at each study visit. The Clinician Administered Dissociative States Scale, a 28-items validated instrument, includes 5 observer items and 23 participant self-report items rated on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). Minimum score :0 not at all; Maximum score 92 extremely dissociate
Measured: Baseline and after ingestion at (120 minutes, 300 minutes)
Cannabis-Specific Subjective Effects
Subjective effects of cannabis will be assessed using both the positive and negative subscales of the Cannabis Experience Questionnaire administered following administration study product. Each item is rated on a 5-point scale, ranging from 1 (not at all) to 5 (severely).The positive subscale includes16 items related to euphoric experiences (maximum 90 and minimum 16). The negative subscale includes 25 items related to paranoid-dysphoric experiences (Maximum 125 and minimum 25).
Measured: T5 (360 minutes after ingestion)
Change in Affect
Affect will be measured using the Positive and Negative Affect Schedule administered at Baseline (T0) and following administration of the study product at each study visit. The Positive and Negative Affect Schedule is a 20-item validated questionnaire divided into subscales of positive (10 items) and negative affect (10 items). Each item is rated on a 5-point scale ranging from 1 (not at all) to 5 (extremely). For each subscale minimum is 10 and maximum 50.
Measured: Baseline and after ingestion at (120 minutes, 300 minutes)
Change in Anxiety Symptoms
Symptoms of anxiety will be assessed using the States-Trait-Anxiety-Inventory, a 20-item validated self-report scale that measures the severity of anxiety in adults. Each symptom is rated on a 4-point scale ranging from 1 (not at all) to 4 (very much).
Measured: Baseline and after ingestion at (120 minutes, 300 minutes)
Change in the incidence of Treatment Emergent-adverse Events
Adverse events will be collected prior to administration of the study product (T0) and following administration of the study product (T1, T2, T3,T4, T5)
Measured: Baseline and after ingestion at (60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
Change on cognition
The Cambridge Neuropsychological Test Automated Battery tests will be used for the rapid assessment of multiple cognitive components.
Measured: Baseline and after ingestion at 210 minutes
Visit Intoxication Assessment
Signs of intoxication will be assess using the modified Standardized Field Sobriety Test.
Measured: End of the visit, approximatively 360 minutes after ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 202214 Nov 2023

First posted7 Jun 2022
Study start22 Jul 2022
Primary completion14 Nov 2023
Study completion14 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CannabisStudies of the same condition, open and under way.
More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05407285
Sponsor's protocol ID: 22.049
Status last verified: Apr 2024
First submitted: 2 Jun 2022
Last updated: 22 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chester LA, Hebert FO, Lachance-Touchette P, Mahroug A, Abboud A, McCrea TP, Mansour S, Marsan S, Jutras-Aswad D. Acute behavioural effects of low-dose cannabidiol: A randomised crossover trial in healthy volunteers. J Psychopharmacol. 2026 Jul 15:2698811261464527. doi: 10.1177/02698811261464527. Online ahead of print.
PubMed 42454450
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;8(1):20. doi: 10.1186/s42238-025-00356-x.
PubMed 41514385

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Triple-blind, Placebo-controlled, Randomized, Crossover Study of Low Dose Oral Synthetic Cannabidiol Effects in Healthy Cannabis Occasional Users
ClinicalTrials.gov ID: NCT05407285
Acronym / sponsor ID: 22.049
Conditions: Cannabis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
Study start: 22 Jul 2022 (actual)
Primary completion: 14 Nov 2023 (actual)
Study completion: 14 Nov 2023 (actual)
First posted: 7 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5
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.

Arm	Type	Receives
0 mg CBD, ingested placebo	Experimental	Drug: cannabis 0 mg, placebo, Drug: Cannabis 20 mg,, Drug: Cannabis 50 mg, Drug: Cannabis 100 mg, Drug: Cannabis 200 mgIngested 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.
20 mg CBD, ingested CBD	Experimental	Drug: cannabis 0 mg, placebo, Drug: Cannabis 20 mg,, Drug: Cannabis 50 mg, Drug: Cannabis 100 mg, Drug: Cannabis 200 mgIngested 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.
50 mg CBD, ingested CBD	Experimental	Drug: cannabis 0 mg, placebo, Drug: Cannabis 20 mg,, Drug: Cannabis 50 mg, Drug: Cannabis 100 mg, Drug: Cannabis 200 mgIngested 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.
100 mg CBD, ingested CBD	Experimental	Drug: cannabis 0 mg, placebo, Drug: Cannabis 20 mg,, Drug: Cannabis 50 mg, Drug: Cannabis 100 mg, Drug: Cannabis 200 mgIngested 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.
200 mg CBD, ingested CBD	Experimental	Drug: cannabis 0 mg, placebo, Drug: Cannabis 20 mg,, Drug: Cannabis 50 mg, Drug: Cannabis 100 mg, Drug: Cannabis 200 mgIngested 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.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cannabis 0 mg, placeboAlso: CBD, placeboEligible 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.	Drug	0 mg CBD, ingested placebo, 100 mg CBD, ingested CBD, 20 mg CBD, ingested CBD, 200 mg CBD, ingested CBD, 50 mg CBD, ingested CBD
Cannabis 20 mg,Also: CBDEligible 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.	Drug	0 mg CBD, ingested placebo, 100 mg CBD, ingested CBD, 20 mg CBD, ingested CBD, 200 mg CBD, ingested CBD, 50 mg CBD, ingested CBD
Cannabis 50 mgAlso: CBDEligible 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.	Drug	0 mg CBD, ingested placebo, 100 mg CBD, ingested CBD, 20 mg CBD, ingested CBD, 200 mg CBD, ingested CBD, 50 mg CBD, ingested CBD
Cannabis 100 mgAlso: CBDEligible 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.	Drug	0 mg CBD, ingested placebo, 100 mg CBD, ingested CBD, 20 mg CBD, ingested CBD, 200 mg CBD, ingested CBD, 50 mg CBD, ingested CBD
Cannabis 200 mgAlso: CBDEligible 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.	Drug	0 mg CBD, ingested placebo, 100 mg CBD, ingested CBD, 20 mg CBD, ingested CBD, 200 mg CBD, ingested CBD, 50 mg CBD, ingested CBD

Primary outcome

Pleasant drug effect
Time frame: T1 (60 minutes after ingestion)
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).
Pleasant drug effect
Time frame: T2 (120 minutes after ingestion)
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).
Pleasant drug effect
Time frame: T3 (210 minutes after ingestion)
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).
Pleasant drug effect
Time frame: T4 (300 minutes after ingestion)
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).
Pleasant drug effect
Time frame: T5 (360 minutes after ingestion)
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).

12 secondary outcomes

Drug Effects associated with cannabis ingestion
Time frame: T1 (60 minutes after ingestion)
Drug Effects associated with cannabis ingestion
Time frame: T2 (120 minutes after ingestion)
Drug Effects associated with cannabis ingestion
Time frame: T3 (210 minutes after ingestion)
Drug Effects associated with cannabis ingestion
Time frame: T4 (300 minutes after ingestion)
Drug Effects associated with cannabis ingestion
Time frame: T5 (360 minutes after ingestion)
Change in dissociation
Time frame: Baseline and after ingestion at (120 minutes, 300 minutes)
Cannabis-Specific Subjective Effects
Time frame: T5 (360 minutes after ingestion)
Change in Affect
Time frame: Baseline and after ingestion at (120 minutes, 300 minutes)
Change in Anxiety Symptoms
Time frame: Baseline and after ingestion at (120 minutes, 300 minutes)
Change in the incidence of Treatment Emergent-adverse Events
Time frame: Baseline and after ingestion at (60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes)
Change on cognition
Time frame: Baseline and after ingestion at 210 minutes
Visit Intoxication Assessment
Time frame: End of the visit, approximatively 360 minutes after ingestion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
Derived from this study: PubMed 42454450Chester LA, Hebert FO, Lachance-Touchette P, Mahroug A, Abboud A, McCrea TP, Mansour S, Marsan S, Jutras-Aswad D. Acute behavioural effects of low-dose cannabidiol: A randomised crossover trial in healthy volunteers. J Psychopharmacol. 2026 Jul 15:2698811261464527. doi: 10.1177/02698811261464527. Online ahead of print.
Derived from this study: PubMed 41514385Abboud 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;8(1):20. doi: 10.1186/s42238-025-00356-x.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Didier Jutras-Aswad, MD,MS principal investigator

Centre hospitalier de l'Université de Montréal (CHUM)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cannabis 20 mg,, Cannabis 50 mg and Cannabis 100 mg in people with Cannabis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pleasant drug effect (time frame: T1 (60 minutes after ingestion)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05407285, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.