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

CompletedPhase 1, Phase 2NCT04976738
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Interventions
  • Drug: Cybis™ 10:25 THC:CBD oil
Sponsor
Cymra Life Sciences
Start date
2021-09-20
Primary completion
2022-06-15
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
Australia
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Aged over 18 years and less than 75 years of age on the date of the Screening Visit; 2. Have back and or neck pain of at least three months duration; 3. Have an average back or neck pain score of between 5 and 9 on a 10-point visual analogue pain scale; 4. Have failed to achieve self-reported satisfactory pain relief using over-the-counter paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs); 5. Are willing to cease all current pain medications 14 days prior to commencing Cybis™ 10:25, and for the duration of the study (except as allowed under rescue medication); Note: Pain medication may include opioids (including but not limited to paracetamol+codeine combinations, codeine, tramadol, tapentadol, buprenorphine), NSAIDs and other co-analgesic medications (such as anti-epileptics, antidepressants, clonidine) and/or any other pain medications. 6. Agree to cease any dietary or herbal supplements (e.g. St John's Wort) fourteen days prior to commencing Cybis™ 10:25, and for the duration of the study; 7. Are willing to cease driving a car or operating heavy machinery from the day of first dosing to seven days after administration of the last dose of Cybis™ 10:25; 8. Agree to use contraception throughout the study, and for one month after the last dose of Cybis™ 10:25 is administered (if reproductive age female) or three months after the last dose of Cybis™ 10:25 is administered (if male); Note: women of childbearing potential must have a negative serum or urine pregnancy test prior to entry into the study. For women, adequate contraception is a double barrier method for the duration of the study and for 30 days post the last study dose. For men, barrier contraception is required for the duration of the study and for 3 months after the last study dose. 9. Agree to adhere to the study protocol; and 10. Are willing and able to provide written informed consent. Exclusion Criteria: 1. Are pregnant or breastfeeding; 2. Currently using marijuana or other medicinal cannabis products; Use of medical cannabis products \> 6 months prior to Screening is acceptable; 3. History of cannabis use disorder (score of 8 or higher on The Cannabis Use Disorder Identification Test - Revised (CUDIT-R); 4. Current or previous allergies or allergic responses to any of the components of the study treatment (e.g., THC, CBD, MCT); 5. Current or previous allergies or allergic responses to any of the components of the rescue medication (e.g. paracetamol, ibupro…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04976738