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

NCT06099379 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-11772
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 control product and 3)To explore qualitatively whether CBD modulates THC effects by mechanisms that are not detected with standard clinical research tools.

Conditions

Cannabis; THC

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (11)

• Positive and Negative Affect

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

• Neural oscillations

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

• Anxiety Symptoms

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

• Subjective Drug Effects

  10 minutes and 80 minutes after inhalation

• Experience with Study Products

  140 minutes after inhalation

Other Outcomes (5)

• Change in plasma concentrations of CBD

  Prior to the Product administration and 5,15, 80, 110, and 140 minutes after administration

• Change in plasma concentrations of THC

  Prior to the Product administration and 5,15, 80, 110, and 140 minutes after administration

• Change in plasma concentrations of Anandamide (AEA)

  Prior to the Product administration and 5,15, 80, 110, and 140 minutes after administration

Study Arms (5)

CBD:THC Group 1

EXPERIMENTAL

Group 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.

Drug: ∆9-tetrahydrocannabinol

CBD:THC Group 2

EXPERIMENTAL

Group 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.

Drug: ∆9-tetrahydrocannabinol

CBD:THC Group 3

EXPERIMENTAL

Group 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.

Drug: ∆9-tetrahydrocannabinol

CBD:THC Group 4

EXPERIMENTAL

Group 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.

Drug: ∆9-tetrahydrocannabinol

CBD:THC Group 5

EXPERIMENTAL

Group 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.

Drug: ∆9-tetrahydrocannabinol

Interventions

∆9-tetrahydrocannabinol DRUG

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

Also known as: Cannabidiol

CBD:THC Group 1; CBD:THC Group 2; CBD:THC Group 3; CBD:THC Group 4; CBD:THC Group 5

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• For female participants:
• 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 control throughout the study.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre de recherche du Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, H2X0A9, Canada

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Didier Jutras-Aswad, MD, MS

  CRCHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Lachance, PhD

CONTACT

514-890-8000; pamela.lachance-touchette.chum@ssss.gouv.qc.ca

François-Olivier Hébert, PhD

CONTACT

581 741-4941; francois-olivier.hebert.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 25, 2023
• Study Start: June 27, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

CA (1)