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CannabisPhase 1/2SPECTRENCT06099379

Modulation of THC Effects by CBD: a Dose-ranging Study

A Phase 1/2 study testing ∆9-tetrahydrocannabinol in people with Cannabis and THC, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 21 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Cannabis, THC
What is being tested?
∆9-tetrahydrocannabinol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
27 Jun 2024to 31 Dec 2026
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 their lifetime and have used cannabis three days or less in the 30 days prior to enrollment;
  • Be able to provide a signed informed consent;
  • Willing to comply with study procedures and requirements as per protocol;
  • Have a forced expiratory volume in first second (FEV) less than or equal to 90 %;
  • Able to communicate and understand English or French language;
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  • For female participants:
  • 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.
  • AND have no pregnancy plan while on the study iii. AND must agree to use a medically accepted method of birth control throughout the study.

Who cannot join

  • 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 visit;
  • Blood pressure higher than 130/80 mmHg;
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  • Kidney disorders;
  • Bleeding disorders;
  • Current moderate or severe DSM-5 substance use disorder (except nicotine) according to 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 cannabis.
  • Participation in clinical studies or undergoing other investigational procedure 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

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Centre de recherche du Centre Hospitalier Universitaire de Montréal

    Montreal, Quebec, H2X0A9

    Pamela Lachance-Touchette, Ph.D, 514 995 5338, pamela.lachance-touchette.chum@ssss.gouv.qc.ca

    Amina Sow, Ph.D, 514 890 8000 ext. 21491, amina.sow.chum@ssss.gouv.qc.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

Despite more than 40 years of research on the active compounds present in the cannabis plant, the influence of CBD consumption on the metabolism, pharmacology, and behavioral effects of THC remains fragmentary and scarcely documented in vivo in humans. Cannabis users are currently encouraged to choose products containing CBD, but evidence is lacking regarding its potential benefits when consumed jointly with THC across different ratios. Given the recent cannabis legalization in Canada and the widespread use of inhalation as the preferred mode of administration for non-therapeutic cannabis, closing this knowledge gap will help ensure public safety and allow regulatory bodies and public health authorities to elaborate more refined cannabis use guidelines and harm reduction strategies. It will also empower people who use cannabis to make more informed purchasing decisions and will drive the incubation of future research endeavors in the fields of medical and social sciences. The aim of this study is to improve our understanding of the (acute) behavioral and pharmacological effects of different doses of CBD administered concomitantly with THC via inhalation in individuals who engage in occasional cannabis use, taking into consideration multiple factors that can modulate such effects. This study will put to the test conceptions surrounding the interaction between specific cannabinoids by evaluating the role of CBD on the modulation of THC's effects pertaining to cognition, behavior, subjective experience, and physiological parameters.

Conditions
Cannabis, THC
Being tested
∆9-tetrahydrocannabinol
Medical subject headings
Marijuana Abuse

What participants receive

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

  • ∆9-tetrahydrocannabinolDrug

    Also called Cannabidiol

    Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled

Study groups in NCT06099379
Study groupRoleWhat they receive
CBD:THC Group 1ExperimentalGroup will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 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: ∆9-tetrahydrocannabinol
CBD:THC Group 2ExperimentalGroup will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 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: ∆9-tetrahydrocannabinol
CBD:THC Group 3ExperimentalGroup will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 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: ∆9-tetrahydrocannabinol
CBD:THC Group 4ExperimentalGroup will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 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: ∆9-tetrahydrocannabinol
CBD:THC Group 5ExperimentalGroup will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 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: ∆9-tetrahydrocannabinol

What is being measured

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

  1. Objective and subjective measures of cannabinoids effect

    Based on the scores obtained on the observer items (objective) and the participant-rated items (subjective) from the Clinician Administered Dissociative State Scale (CADSS). The CADSS is a 28-item 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) on eight items. The score will reflect the extent to which participants were observed to be under the effect of cannabinoids, i.e., in adissociative state.

    Measured: Prior to the Product administration ,10 minutes and 80 minutes after inhalation

Secondary outcomes (11)
  1. Positive and Negative Affect

    Will be measured by the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item validated questionnaire, used in both non-clinical and clinical populations.

    Measured: Prior to the Product administration , 10 minutes and 80 minutes post inhalation

  2. Neural oscillations

    Auditory oscillations, using an electroencephalogram (EEG), will be probe in response to 40-Hz FM and ascending/descending AM stimuli, using a 16-channel system with 250-Hz sampling rate and 24-bit resolution (model g.Nautilus PRO 16 g.SAHARA, g.tec, Schiedlberg, Austria).

    Measured: Prior to the Product administration, 80 minutes post inhalation and at the end of the study visit, approximatively 140 minutes after inhalation

  3. Anxiety Symptoms

    Symptoms of anxiety will be assessed using the States-Trait-Anxiety-Inventory (STAI). It consists of two 20-item self-report scales (trait and state anxiety) that measure the severity of anxiety in adults. Both subscales are composed of 20 statements rated on a 4-point Likert scale ranging from 1 ("not at all" and "almost never" for the state and trait subscales, respectively) to 4 ("very much" and "almost always" for the state and trait subscales, respectively).

    Measured: Prior to the Product administration, 10 minutes and 80 minutes after inhalation

  4. Subjective Drug Effects

    Drug Effect Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis inhalation and desire to use the product. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).

    Measured: 10 minutes and 80 minutes after inhalation

  5. Experience with Study Products

    Subjective effects of cannabis will be assessed using the Cannabis Experience Questionnaire (CEQ), The CEQ measures participants' subjective experiences with cannabis consumption and consists of two subscales: pleasurable experiences (18 items), psychosis-like experiences (25 items), and after-effect experiences measuring the consequences of cannabis after use (12 items). Each item of each subscale is rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely).

    Measured: 140 minutes after inhalation

  6. Social Exposition Challenge

    This will help determine if different doses of CBD can modulate the feeling of paranoia and/or anxiety triggered by social interactions, in comparison to the control product. The research staff will give to the participant five dollars in cash. The participant will then be escorted out of the research center by a member of the research staff for a 10-minute walk to the hospital pharmacy with the instruction of purchasing an item of their choosing with the money. Once the task is completed, the participant will be escorted back to the research center. The research staff will walk approximately two meters behind the participant during the whole procedure and will be instructed not to engage in any conversation, unless the participant needs assistance or feels abnormally anxious.

    Measured: 70 minutes after inhalation

  7. Change on cognition

    The Cambridge Neuropsychological Test Automated Battery tests will be used for the rapid assessment of multiple cognitive components.

    Measured: Prior to the Product administration (only at Visite 1) and 10 minutes after inhalation at each visit

  8. Success of Blinding Questionnaire

    To assess the success of the blind iwith the Blinding Success Questionnaire (BSQ). The specific aims of testing the blind are to a) determine which research product participants think they received and b) examine the associations between the research product participants think they received and their expectations, subjective cannabis perceptions, treatment outcomes, and side effects.

    Measured: 10 minutes and 140 minutes after inhalation

  9. Inhalation Adherence

    When the participant inhales the investigational product, research staff will fill a questionnaire assessing participant compliance.

    Measured: During inhalation procedure

  10. 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,10 minutes, 80 minutes and 140 minutes after inhalation

  11. Visit Intoxication Assessment

    Signs of intoxication will be assess using the modified Standardized Field Sobriety Test.

    Measured: Through study visit completion, approximatively 140 minutes after product inhalation

Timeline

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

  1. First posted25 Oct 2023
  2. Study start27 Jun 2024
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
In this crossover design, participants will be administered all phytocannabinoid doses contained in the four CBD:THC products and the control product (THC only) during participation in the study. Participant will be randomly assigned to one of the predetermined sequences with a CBD:THC product or control product at 5 dosages (CBD:THC of 0:20 mg, 20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg). Participants will be randomized based on a balanced 5 by 5 Latin square.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06099379
Sponsor's protocol ID
2024-11772
Acronym
SPECTRE
Status last verified
Dec 2025
First submitted
29 Sep 2023
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ∆9-tetrahydrocannabinol in people with Cannabis and THC, 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 9 inclusion and 16 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: looking for participants now, 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.

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?

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?

Objective and subjective measures of cannabinoids effect (time frame: Prior to the Product administration ,10 minutes and 80 minutes after inhalation). 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; AzTrials last refreshed its copy on 29 Oct 2026.

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