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
This trial accepts healthy volunteersQualifiers
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
Crossover
Treatments tested in this trial
∆9-tetrahydrocannabinol
DrugPhytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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).
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).
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).
Other outcomes
Change in plasma concentrations of CBD
Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry.
Change in plasma concentrations of THC
Plasma levels of THC will be determined by high performance liquid chromatography-tandem mass spectrometry.
Change in plasma concentrations of Anandamide (AEA)
Plasma levels of CBD and THC will be determined by high performance liquid chromatography-tandem mass spectrometry.
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.
Sponsors and contacts
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