None listed
Conditions
Brief summary
This trial will investigate the single dose pharmacokinetics of two sublingually administered cannabis products, one CBD dominant the other THC dominant. This data will be used to inform dosing decisions in other trials. A secondary objective of this trial is to identify at what point do subjects begin to feel the intoxicating effects of these products and for how long they last.
Interventions
Cohort 1: Single dose sublingually 2ml administration of a cannabis tincture containing 50mg Cannabidiol (CBD) and 1.9mg delta-9-Tetrahydrocannabinol (THC) per ml in solution with MCT oil. Participants must hold the tincture under their tongue for 60 seconds before swallowing.
Cohort 2: Single dose sublingually 2ml administration of a cannabis tincture containing 0mg CBD and 2.5mg THC per ml in solution with MCT oil. Participants must hold the tincture under their tongue for 60 seconds before
Cohort 1: Single dose sublingually 2ml administration of a cannabis tincture containing 50mg Cannabidiol (CBD) and 1.9mg delta-9-Tetrahydrocannabinol (THC) per ml in solution with MCT oil. Participants must hold the tincture under their tongue for 60 seconds before swallowing. Cohort 2: Single dose sublingually 2ml administration of a cannabis tincture containing 0mg CBD and 2.5mg THC per ml in solution with MCT oil. Participants must hold the tincture under their tongue for 60 seconds before swallowing.
Sponsors
Soma Group Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
The key exclusion criteria are: *Willing and able to give informed consent and be between 25 and 75 years of age *Willing and able to commit to a full day eight hour experiment session *Willing and able to attend therapy sessions once a month and complete other assessments when required *If applicable be willing and able to provide evidence of a negative pregnancy test taken no more than 72 hours prior to participating in the study
Exclusion criteria
The key exclusion criteria are: *Any family or personal history of psychosis *Any history of cardiovascular disorders *Currently taking any other medications (other than birth control) *Must not be taking any herbal remedies e.g. Saint John's Wort *Any diagnosis of a DSM-V qualifying condition *Have any other current health condition that requires pharmaceutical treatment. *Participants must not have used any other cannabis product for at least one month prior to study entry or use any other cannabis product during the study
Outcome results
None listed