A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users

ConditionCannabis
Trial statusNot yet recruiting
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 the administration of different low doses of CBD (5 mg, 20 mg, 50 mg and 100 mg) result in detectable subjective pleasant drug effect compared to placebo and 2) to qualitatively explore whether low dose CBD is associated with effects that are not detected with the available research tools.

Eligibility criteria

Qualifiers

Between 21 and 49 years of age, inclusively;

Have used cannabis at least once in lifetime AND have used cannabis three days or less in the 28 days prior to enrollment;

Be able to provide a signed informed consent;

Willing to comply with study procedures and requirements as per protocol, including to abstain from using other cannabis products or any drugs (except alcohol or nicotine) 7 days prior to study visits;

Disqualifiers

Any disabling medical conditions, 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 (e.g. history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current suicidality, acute depression or anxiety disorder 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 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

  • Cannabis, placebo

Treatment groups

80 Participants
are divided into 5 treatment groups

Locations

This trial has no locations