Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in plasma concentrations of CBD |
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry. |
Prior to the Product administration and 5,15, 80, 110, and 140 minutes after administration |
|
Other |
Change in plasma concentrations of THC |
Plasma levels of THC will be determined by high performance liquid chromatography-tandem mass spectrometry. |
Prior to the Product administration and 5,15, 80, 110, and 140 minutes after administration |
|
Other |
Change in plasma concentrations of Anandamide (AEA) |
Plasma levels of CBD and THC will be determined by high performance liquid chromatography-tandem mass spectrometry. |
Prior to the Product administration and 5,15, 80, 110, and 140 minutes after administration |
|
Other |
Change in plasma concentrations of 2-Arachidonoylglycerol (2-AG) |
Plasma levels of CBD and THC will be determined by high performance liquid chromatography-tandem mass spectrometry. |
Prior to the Product administration and 5,15, 80, 110, and 140 minutes after administration |
|
Other |
Genetic markers |
To explore potential genetic factors that could explain at least in part some of the participants' responses to the study outcomes and that have been associated with specific candidate genes (e.g., COMT, AKT1, DRD2, FAAH and cytochrome P450 genes). Using buccal swabs from EndoDNA test kits. These DNA tests will be used to map known genetic variants associated with the endocannabinoidome and related physiological systems to identify specific genotypes that correlate with neurocognitive and behavioral effects measured for each study product for an example application of the method). |
Baseline, Prior to the Product administration (only at visite 1) |
|
Primary |
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 |
Positive and Negative Affect |
Will be measured by the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item validated questionnaire, used in both non-clinical and clinical populations. |
Prior to the Product administration , 10 minutes and 80 minutes post inhalation |
|
Secondary |
Neural oscillations |
Auditory oscillations, using an electroencephalogram (EEG), will be probe in response to 40-Hz FM and ascending/descending AM stimuli, using a 16-channel system with 250-Hz sampling rate and 24-bit resolution (model g.Nautilus PRO 16 g.SAHARA, g.tec, Schiedlberg, Austria). |
Prior to the Product administration, 80 minutes post inhalation and at the end of the study visit, approximatively 140 minutes after inhalation |
|
Secondary |
Anxiety Symptoms |
Symptoms of anxiety will be assessed using the States-Trait-Anxiety-Inventory (STAI). It consists of two 20-item self-report scales (trait and state anxiety) that measure the severity of anxiety in adults. Both subscales are composed of 20 statements rated on a 4-point Likert scale ranging from 1 ("not at all" and "almost never" for the state and trait subscales, respectively) to 4 ("very much" and "almost always" for the state and trait subscales, respectively). |
Prior to the Product administration, 10 minutes and 80 minutes after inhalation |
|
Secondary |
Subjective Drug Effects |
Drug Effect Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis inhalation and desire to use the product. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely). |
10 minutes and 80 minutes after inhalation |
|
Secondary |
Experience with Study Products |
Subjective effects of cannabis will be assessed using the Cannabis Experience Questionnaire (CEQ), The CEQ measures participants' subjective experiences with cannabis consumption and consists of two subscales: pleasurable experiences (18 items), psychosis-like experiences (25 items), and after-effect experiences measuring the consequences of cannabis after use (12 items). Each item of each subscale is rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely). |
140 minutes after inhalation |
|
Secondary |
Social Exposition Challenge |
This will help determine if different doses of CBD can modulate the feeling of paranoia and/or anxiety triggered by social interactions, in comparison to the control product. The research staff will give to the participant five dollars in cash. The participant will then be escorted out of the research center by a member of the research staff for a 10-minute walk to the hospital pharmacy with the instruction of purchasing an item of their choosing with the money. Once the task is completed, the participant will be escorted back to the research center. The research staff will walk approximately two meters behind the participant during the whole procedure and will be instructed not to engage in any conversation, unless the participant needs assistance or feels abnormally anxious. |
70 minutes after inhalation |
|
Secondary |
Change on cognition |
The Cambridge Neuropsychological Test Automated Battery tests will be used for the rapid assessment of multiple cognitive components. |
Prior to the Product administration (only at Visite 1) and 10 minutes after inhalation at each visit |
|
Secondary |
Success of Blinding Questionnaire |
To assess the success of the blind iwith the Blinding Success Questionnaire (BSQ). The specific aims of testing the blind are to a) determine which research product participants think they received and b) examine the associations between the research product participants think they received and their expectations, subjective cannabis perceptions, treatment outcomes, and side effects. |
10 minutes and 140 minutes after inhalation |
|
Secondary |
Inhalation Adherence |
When the participant inhales the investigational product, research staff will fill a questionnaire assessing participant compliance. |
During inhalation procedure |
|
Secondary |
Change in Safety |
Adverse events will be collected prior to administration of the study product (T0) and following administration of the study product (T1, T2 and T3). |
Baseline,10 minutes, 80 minutes and 140 minutes after inhalation |
|
Secondary |
Visit Intoxication Assessment |
Signs of intoxication will be assess using the modified Standardized Field Sobriety Test. |
Through study visit completion, approximatively 140 minutes after product inhalation |
|