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

ConditionsCannabisTHC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21-49
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • ∆9-tetrahydrocannabinol

Treatment groups

100 Participants
are divided into 5 treatment groups