NCT04976738

A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain

A Dose-ranging Study to Examine the Pharmacokinetics, Safety, Tolerability and Efficacy of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Cymra Life Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomised, single arm, open-label study of medical cannabis, Cybis™ 10:25, in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.

Detailed description

This is a non-randomised, single arm, open-label study of Cybis™ 10:25 in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25. The purpose of the study is to demonstrate the safety and tolerability of Cybis™ 10:25 in participants with moderate to severe chronic back or neck pain that is unresponsive to over-the-counter non-opioid analgesics. Participants will undergo a screening visit, then seven clinic visits (Day 1, 2, 8, 15, 22, 29, and 35). Cybis™ 10:25 will be administered oromucosally at doses varying from 0.5 mL once daily to 1.5 mL twice daily. Total duration of dosing is 28 days.

Conditions

• Chronic Pain
• Neck Pain
• Back Pain
• Pain
• Pain, Chronic
• Pain, Back
• Pain, Neck
• CBD
• THC

Interventions

Type	Name	Description
DRUG	Cybis™ 10:25 THC:CBD oil	Cybis™ 10:25 containing 10 mg/mL of D9-THC and 25 mg/mL of CBD, formulated in medium chain triglycerides (MCT)

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-06-15
• Completion: 2022-06-21
• First posted: 2021-07-26
• Last updated: 2022-07-07

Locations

2 sites across 1 country: Australia