Comparing 5 approaches for cannabis
Official title: Modulation of THC Effects by CBD: a Dose-ranging Study
Modulation of ∆9-tetrahydrocannabinol Acute Psychoactive Effects by Ranging Doses of Cannabidiol in Healthy, Occasional Cannabis Users: a Controlled, Triple Blind, Randomized, Cross-over Study
- Phase 1
- 5 groups
- One site, in Montreal
- Recruiting
Interventions
- Medication
∆9-tetrahydrocannabinol
Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Centre de recherche du Centre Hospitalier Universitaire de Montréal
Montreal, Quebec
Eligibility Criteria
See who this study is looking for42 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Between 21 and 49 years of age, inclusively;
- +Have used cannabis at least once in their lifetime and have used cannabis three days or less in the 30 days prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →;
- +Be able to provide a signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- +Willing to comply with study procedures and requirements as per protocolProtocolThe detailed plan a study must follow.Read more →;
- +Have a forced expiratory volume in first second (FEV) less than or equal to 90 %;
- +Able to communicate and understand English or French language;
- +For female participants:
- +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Participants will be excluded if any of the following criteria are met:
- +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;
- +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;
- +Known chronic liver disease or aspartate transaminase/alanine transaminase (AST/ALT) two times higher than upper limit of normal values at screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →;
- +Blood pressure higher than 130/80 mmHg;
- +Kidney disorders;
- +Bleeding disorders;
- +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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may interact with cannabis.
- +Participation in clinical studies or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +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.
- +a. No 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. For female of childbearing potential: i. Must have negative pregnancy test result at screening and at subsequent visits.
- +ii. AND have no pregnancy plan while on the study iii. AND must agree to use a medically accepted method of birth controlControl groupThe group a new treatment is measured against.Read more → throughout the study.
- +Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;
- +Current moderate or severe DSM-5 substance use disorder (except nicotine) according to SCID-V;
Exclusion
- −Participants will be excluded if any of the following criteria are met:
- −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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- −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;
- −Known chronic liver disease or aspartate transaminase/alanine transaminase (AST/ALT) two times higher than upper limit of normal values at screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →;
- −Blood pressure higher than 130/80 mmHg;
- −Kidney disorders;
- −Bleeding disorders;
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may interact with cannabis.
- −Participation in clinical studies or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −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.
- −Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the study;
- −Current moderate or severe DSM-5 substance use disorder (except nicotine) according to SCID-V;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 5 groups in this study.
Groups A, B, C, D and E receive ∆9-tetrahydrocannabinol.
Registry label: A: CBD:THC Group 1 · B: CBD:THC Group 2 · C: CBD:THC Group 3 · D: CBD:THC Group 4 · E: CBD:THC Group 5
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 21 years to 49 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Prior to the Product administration ,10 minutes and 80 minutes after inhalation.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Objective and subjective measures of cannabinoids effect — measured over Prior to the Product administration ,10 minutes and 80 minutes after inhalation.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06099379 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ∆9-tetrahydrocannabinolDrug
Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 21 years to 49 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 21 years to 49 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Prior to the Product administration ,10 minutes and 80 minutes after inhalation.
The study as a whole is currently expected to finish around 2026-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purposes of this study are 1) to determine if CBD modulates THC-induced acute psychoactive effects at different CBD:THC ratios, compared with the control product (0:20, 20:20, 40:20, 80:20, 120:20) and 2) to determine if different doses of CBD modulate other THC induced behavioral effects, compared with the control product and 3)To explore qualitatively whether CBD modulates THC effects by mechanisms that are not detected with standard clinical research tools.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.