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

NCT04976738 | Completed Phase 1 DMC

• 1 other identifier: CYM-001-21
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Pain; Neck Pain; Back Pain; Pain; Pain, Chronic; Pain, Back; Pain, Neck; CBD; THC

Keywords

medical cannabis; THC; CBD; chronic pain; neck pain; back pain; pain; dose-ranging; dose-finding

Outcome Measures

Primary Outcomes (9)

• Number (and percentage) of participants with one or more adverse event

  To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.

  Safety and tolerability will be assessed throughout the trial. Up to 35 days.

• Number (and percentage) of participants with one or more adverse event of special interest

  To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.

  Safety and tolerability will be assessed throughout the trial. Up to 35 days.

• Number (and percentage) of participants with one or more serious adverse events

  To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.

  Safety and tolerability will be assessed throughout the trial. Up to 35 days.

• Adverse events, adverse events of special interest, serious adverse events will be summarised descriptively with the number of participants experiencing the event and the percentages of participants experiencing the event.

  To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.

  Safety and tolerability will be assessed throughout the trial. Up to 35 days.

• Number (and percentage) of participants with changes in vital signs

  To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.

  Safety and tolerability will be assessed throughout the trial. Up to 35 days.

• Number (and percentage) of participants with clinically relevant changes in physical examination

  To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.

  Safety and tolerability will be assessed throughout the trial. Up to 35 days.

• Number (and percentage) of participants with clinically relevant changes in clinical chemistry

  To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.

  Safety and tolerability will be assessed throughout the trial. Up to 35 days.

• Number (and percentage) of participants who drop-out

  To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.

  Safety and tolerability will be assessed throughout the trial. Up to 35 days.

• Number (and percentage) of participants who withdraw due to adverse events

  To assess the safety and tolerability of Cybis™ 10:25 at low (0.5 mL qd), medium-low (0.5 mL bd), medium (1.0 mL bd) and high (1.5 mL bd) doses.

  Safety and tolerability will be assessed throughout the trial. Up to 35 days.

Secondary Outcomes (14)

• To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Peak plasma concentration (Cmax) of THC in plasma.

  Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.

• To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Time to maximum concentration (tmax) of THC in plasma.

  Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.

• To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Area under the concentration/time curve (AUC) will be calculated for THC.

  Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.

• To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. The elimination half-life (t1/2) will be calculated for THC.

  Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.

• To investigate the pharmacokinetics of Cybis™ 10:25 in participants with chronic back and neck pain following single and repeated doses. Peak plasma concentration (Cmax) of CBD in plasma.

  Up to 29 days. Samples collected at baseline 0 (pre-dose), 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12.0, and 24.0 hours post dosing. Day 8, 15, 22 and 29 trough levels.

Study Arms (1)

Treatment arm: Cybis™ 10:25 THC:CBD oil

EXPERIMENTAL

Cybis™ 10:25 THC:CBD oil administered oromucosally at doses varying from 0.5 mL once daily to 1.5 mL twice daily. Total duration of dosing is 28 days.

Drug: Cybis™ 10:25 THC:CBD oil

Interventions

Cybis™ 10:25 THC:CBD oil DRUG

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

Treatment arm: Cybis™ 10:25 THC:CBD oil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 18 years and less than 75 years of age on the date of the Screening Visit;
• Have back and or neck pain of at least three months duration;
• Have an average back or neck pain score of between 5 and 9 on a 10-point visual analogue pain scale;
• Have failed to achieve self-reported satisfactory pain relief using over-the-counter paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs);
• 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.
• 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;
• 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;
• 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.
• Agree to adhere to the study protocol; and
• Are willing and able to provide written informed consent.

You may not qualify if:

• Are pregnant or breastfeeding;
• Currently using marijuana or other medicinal cannabis products; Use of medical cannabis products \> 6 months prior to Screening is acceptable;
• History of cannabis use disorder (score of 8 or higher on The Cannabis Use Disorder Identification Test - Revised (CUDIT-R);
• Current or previous allergies or allergic responses to any of the components of the study treatment (e.g., THC, CBD, MCT);
• Current or previous allergies or allergic responses to any of the components of the rescue medication (e.g. paracetamol, ibuprofen, aspirin, other NSAIDs);
• Significant cardiac disease (e.g. poorly controlled hypertension, symptomatic ischaemic heart disease, symptomatic heart failure);
• Chronic liver disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 times the upper level or normal limits;
• Chronic renal impairment with eGFR \<30mL/min;
• Taking sildenafil or other PDE5 inhibitors;
• Being treated with known inducers/inhibitors of CYP3A4, in particular clarithromycin, rifampicin, azole antifungals, antiretroviral agents, anticonvulsants (phenytoin, carbamazepine), SSRI within 30 days of study commencement; Use of such enzyme-altering agents is prohibited throughout the study.
• Have a major psychiatric disorder (e.g. schizophrenia, psychosis, bipolar disorder, but not anxiety or depression), by history or examination;
• Are currently using any illicit drug (including, but not limited to, amphetamines, cocaine);
• Have a history of other substance abuse disorder (as defined by DSM-5);
• Have active substance abuse disorder (alcohol, illicit drugs);
• Other clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, or vital signs, which in the opinion of the Investigator, may put the participant at risk of adverse events;

Sponsors & Collaborators

• Cymra Life Sciences: lead

Study Sites (2)

ACRN - Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2000, Australia

Location

MeSH Terms

Conditions

Chronic Pain; Neck Pain; Back Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Chye

  Cymra Life Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 26, 2021
• Study Start: September 20, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 21, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)