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.
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;
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;
Crossover
Cannabis, placebo
DrugEligible participant will be randomize 1:1:1:1:1 to receive placebo, CBD (5mg, 20mg, 50mg and 100mg). Only one research product will be inhaled for each visit. The sequence will depend on the assigned randomization group.
Pleasant drug effect
Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).
Pleasant drug effect
Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).
Pleasant drug effect
Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).
Drug Effects associated with cannabis administration
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Drug Effects associated with cannabis administration
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Drug Effects associated with cannabis administration
Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).
Change in dissociation
Dissociation will be assessed using the Clinician Administered Dissociative States Scale (CADSS) administered at Baseline (T0) and following administration of the study product (T1- 10 minutes, T2-60 minutes) at each study visit. The CADSS, a 28-items 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). Minimum score :0 not at all; Maximum score 72 extremely dissociate.
Change in plasma concentration of CBD
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
Change in plasma concentration of 7-Hydroxycannabidiol
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
Change in plasma concentration of 7-Carboxy-Cannabidiol
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
Change in plasma concentration of Anandamide
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.
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