None listed
Conditions
Brief summary
There is some evidence that cannabinoids may enable patients to reduce their opioid medication whilst maintaining adequate analgesia - known as opioid sparing. If so, cannabinoids could prove effective in reducing drop-out rates in opioid dose taper regimen, assisting patients with poorly managed pain. This protocol is a preliminary dose escalation pharmacokinetic study which will evaluate the safety and tolerability of a cannabinoid (THC:CBD) oil formulation following a single dose and following repeated dosing in patients with chronic non-cancer pain. The data from this pharmacokinetic study will inform a subsequent trial which will assess the impact of oral CBD/THC combination oil on patient ability to tolerate a stepped opioid tapering protocol at a rate of 10% per week over 10 weeks.
Interventions
This study is an open label dose-escalation pharmacokinetic study which will evaluate the safety and tolerability of an oral cannabinoid (THC:CBD) oil formulation following a single dose and following repeated dosing in patients with chronic non-cancer pain. The study will consist of 5 stages:
Stage 1: A single dose of 2.5mg THC/2.5mg CBD
Stage 2: A single dose of 2.5mg THC/2.5mg CBD following a high-fat meal and then a total daily dose of 5mg THC/5mg CBD (twice per day) for a week
Stage 3: A si
This study is an open label dose-escalation pharmacokinetic study which will evaluate the safety and tolerability of an oral cannabinoid (THC:CBD) oil formulation following a single dose and following repeated dosing in patients with chronic non-cancer pain. The study will consist of 5 stages: Stage 1: A single dose of 2.5mg THC/2.5mg CBD Stage 2: A single dose of 2.5mg THC/2.5mg CBD following a high-fat meal and then a total daily dose of 5mg THC/5mg CBD (twice per day) for a week Stage 3: A single dose of 5mg THC/5mg CBD followed by a total daily dose of 10mg THC/10mg CBD (twice per day) for a week Stage 4: A single dose of 7.5mg THC/7.5mg CBD followed by a total daily dose of 15mg THC/15mg CBD (twice per day) for a week Stage 5: A single dose of 12.5mg THC/12.5mg CBD In Stage 1, participants will receive a single dose of 2.5mg THC/2.5mg CBD and bloods will be taken for pharmacokinetic (PK) analysis, after which there will be a 7 day washout period. In Stage 2, participants will receive a single dose of 2.5mg THC/2.5mg CBD immediately following a high fat meal and bloods will be taken for PK analysis. Participants then continue to take 2.5mg THC/2.5mg CBD twice per dose (total daily dose of 5mg THC/5mg CBD) for one week. The high fat breakfast will be consistent with the Food and Drug Administration guidelines for fat and calorific content and will be consumed 30minutes before consumption of the cannabis oil. In Stage 3, participants will receive a single dose of 5mg THC/5mg CBD and bloods will be taken for PK analysis. Participants then continue to take 5mg THC/5mg CBD twice per day (total daily dose of 10mg THC/10mg CBD) for one week. In Stage 4, participants will receive a single dose of 7.5mg THC/7.5mg CBD and bloods will be taken for PK analysis. Participants then continue to take 7.5mg THC/7.5mg CBD twice per day (total daily dose of 15mg THC/15mg CBD) for one week. In Stage 5, participants will receive a single dose of 12.5mg THC/12.5mg CBD and bloods will be taken for PK analysis. Participants then have a 7 day washout period before returning for the close-out examination. All participants will progress through the five stages. The total time taken to complete all stages is 36 days. The cannabinoid (THC:CBD) oil formulation will be orally delivered using an oral syringe. Adherence to the self-dosing schedule will be monitored by having participants return all (used and unused) oral syringes at each site visit. Three participants will be selected to wear an Actigraph activity monitoring wrist watch commencing on day 2 of the study. The activity monitoring watch will be continuously worn by the participant for the duration of the trail.
Sponsors
Zelda Therapeutics
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Chronic non-cancer pain on long term treatment (>12months) with high dose (OMEDD >60mg) opioid analgesia. Willing to cease driving a motor vehicle for the duration of the study. No cannabis use in the last month.
Exclusion criteria
Dependence on cannabis. Cardiovascular disorder, epilepsy, psychosis, bipolar disorder, 1st degree relative with psychosis. Dependence on alcohol, benzodiazepines, or amphetamine type stimulants. Evidence of severe hepatic/renal impairment. Active malignancy. Females who are pregnant, lactating or not using adequate contraception. Males who are not using adequate contraception.
Outcome results
None listed