A study to evaluate the safety, tolerability, and pharmacokinetics of a medicinal cannabinoid oil formulation in chronic non-cancer pain participants on long term opioid treatments

Phase 1

Completed

• Conditions: chronic pain; Anaesthesiology - Pain management

• Registration Number: ACTRN12619001013156
• Lead Sponsor: Zelda Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-15
• Study Completion: 2020-04-09
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of a THC:CBD formulation following a single oral dose and following repeated doses.<br>Safety will be assessed using a composite of measures:<br>1. Adverse events (AEs) will be coded and presented using MedDRA. The overall incidence, the incidence of related as well as the incidence of serious adverse events (SAEs) will be summarized per dose and by body system in tables. <br>2. Vital signs (supine blood pressure, heart rate, body temperature and respiratory rate) collected during weekly clinical assessments: Descriptive statistics (n, mean, standard deviation, median, minimum, and maximum) will be provided for blood pressure, heart rate, body temperature and respiratory rate and for changes from baseline<br>[Weekly, at each dose escalation visit and at day 36 post-enrolment.];Local tolerability (assessed by a persons ability to orally swallow the investigational product) will be presented by overall incidence by treatment group per symptom.[Assessed at each dose escalation]