Actively Recruiting

Phase 1
Phase 2
Age: 21Years - 49Years
All Genders
Healthy Volunteers
NCT06099379

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

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-12-22

100

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years - 49Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 21 and 49 years of age, inclusively
  • Have used cannabis at least once in their lifetime
  • 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
  • Have a forced expiratory volume in first second (FEV) less than or equal to 90 %
  • Able to communicate and understand English or French
  • For female participants with no childbearing potential: postmenopausal for at least 12 months and 45 years or older, or surgically sterilized
  • For female participants with childbearing potential: negative pregnancy test at screening and subsequent visits, no pregnancy plan during study, and use of medically accepted birth control throughout the study
Not Eligible

You will not qualify if you...

  • Any disabling medical condition that precludes safe participation or informed consent
  • Severe psychiatric conditions including schizophrenia, schizoaffective disorder, bipolar disorder, current acute psychosis, mania, or suicidality
  • Other disabling, unstable, or acute mental conditions preventing safe participation or consent
  • Known chronic liver disease or elevated liver enzymes at screening
  • Blood pressure higher than 130/80 mmHg
  • Kidney disorders
  • Bleeding disorders
  • Current moderate or severe substance use disorder (except nicotine)
  • Currently pregnant, breastfeeding, or planning pregnancy during the study
  • Pending legal action or other issues preventing study completion
  • Use of medication within 7 days prior to sessions that may interact with cannabis
  • Participation in other cannabis or cannabinoid studies within 30 days before randomization
  • Resting heart rate over 100 beats per minute
  • Body mass index over 29.9 kg/m2
  • Clinically significant electrocardiogram abnormalities at screening visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre de recherche du Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada, H2X0A9

Actively Recruiting

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Research Team

P

Pamela Lachance, PhD

CONTACT

F

François-Olivier Hébert, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

5

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