CannabisPhase 1/2NCT05320367
A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
A Phase 1/2 study of Cannabis, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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
- 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 must agree to use a medically accepted method of birth control throughout the study.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Triple Blinded Cross-over Placebo Controlled Study of Effects of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
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.
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 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.
- Conditions
- Cannabis
- Being tested
- Cannabis, placebo
- 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, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Cannabis, placebo |
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(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).
Measured: 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).
Measured: T3 (140 minutes after inhalation)
Secondary outcomes (10)
Drug Effects associated with cannabis administration
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Measured: T1 (10 minutes after inhalation)
Drug Effects associated with cannabis administration
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Measured: T2 (80 minutes after inhalation)
Drug Effects associated with cannabis administration
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Measured: T3 (140 minutes after inhalation)
Change in dissociation
Dissociation will be assessed using the Clinician Administered Dissociative States Scale (CADSS) administered at Baseline (T0) and following administration of the study product (T1- 10 minutes, T2-60 minutes) at each study visit. The CADSS, 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 72 extremely dissociate.
Measured: Baseline and after inhalation at (10 minutes, 80 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: T3 (140 minutes after inhalation)
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 inhalation at (10 minutes, 80 minutes, 140 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 inhalation at (10 minutes, 80 minutes and 140 minutes)
Change in Safety
Adverse events will be collected prior to administration of the study product (T0) and following administration of the study product (T1, T2 and T3)
Measured: Baseline and after inhalation at (10 minutes, 80 minutes, 140 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 inhalation at T2 (80 minutes).
Visit Intoxication Assessment
Signs of intoxication will be assess using the modified Standardized Field Sobriety Test.
Measured: End of the visit, approximatively 180 minutes after inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Jutras-Aswad, MD,MS, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320367
- Sponsor's protocol ID
- 21.361
- Status last verified
- Dec 2025
- First submitted
- 20 Mar 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple Blinded Cross-over Placebo Controlled Study of Effects of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
- ClinicalTrials.gov ID
- NCT05320367
- Acronym / sponsor ID
- 21.361
- Conditions
- Cannabis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Apr 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.
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.
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
- 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
| Arm | Type | Receives |
|---|---|---|
| CBD (Group 1) | Experimental | Drug: Cannabis, placeboGroup 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 |
| CBD (Group 2) | Experimental | Drug: Cannabis, placeboGroup 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 |
| CBD (Group 3) | Experimental | Drug: Cannabis, placeboGroup 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. |
| CBD (Group 4) | Experimental | Drug: Cannabis, placeboGroup 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. |
| CBD (Group 5) | Experimental | Drug: Cannabis, placeboGroup 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. |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 %;
Key exclusion criteria (15 listed)
- 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;
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, placeboEligible 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. | Drug | CBD (Group 1), CBD (Group 2), CBD (Group 3), CBD (Group 4), CBD (Group 5) |
Primary outcome
Pleasant drug effect
Time frame: T1(10 minutes after inhalation)
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 (80 minutes after inhalation)
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 (140 minutes after inhalation)
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).
10 secondary outcomes
Drug Effects associated with cannabis administration
Time frame: T1 (10 minutes after inhalation)
Drug Effects associated with cannabis administration
Time frame: T2 (80 minutes after inhalation)
Drug Effects associated with cannabis administration
Time frame: T3 (140 minutes after inhalation)
Change in dissociation
Time frame: Baseline and after inhalation at (10 minutes, 80 minutes)
Cannabis-Specific Subjective Effects
Time frame: T3 (140 minutes after inhalation)
Change in Affect
Time frame: Baseline and after inhalation at (10 minutes, 80 minutes, 140 minutes)
Change in Anxiety Symptoms
Time frame: Baseline and after inhalation at (10 minutes, 80 minutes and 140 minutes)
Change in Safety
Time frame: Baseline and after inhalation at (10 minutes, 80 minutes, 140 minutes)
Change on cognition
Time frame: Baseline and after inhalation at T2 (80 minutes).
Visit Intoxication Assessment
Time frame: End of the visit, approximatively 180 minutes after inhalation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- 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.
Didier Jutras-Aswad, MD,MS principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Cannabis, run by Centre hospitalier de l'Université de Montréal (CHUM).
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 10 inclusion and 15 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: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Lachance, PhD (514-890-8000 ext. 30938, pamela.lachance-touchette.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleasant drug effect (time frame: T1(10 minutes after inhalation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.