None listed
Conditions
Brief summary
This Phase 2 clinical trial examines the role of different types of medicinal cannabis (MC) products for managing chronic low back pain in people with opioid dependence. The study will compare three types of oral MC products (THC, CBD and THC/CBD combination) against placebo on a range of outcomes, including pain severity, pain interference, mood, anxiety, substance use, sleep, safety (adverse events, abuse liability) and participant experience. Each participant will experience all four medication conditions.
Interventions
Phase II double-blind, randomised within-subject crossover study where each participant is exposed to 4 conditions in random and sequential order: (A) Placebo, oral liquid; (B) Tetrahydrocannabinol (THC) only (20mg daily), oral liquid; (C) Tetrahydrocannabinol (THC) - Cannabidiol (CBD) (20mg-400mg), oral liquid and (D) Cannabidiol (CBD) only (400mg), oral liquid. Each participant will be exposed to two weeks of study medication per condition, with a one-week washout period between conditions, re
Phase II double-blind, randomised within-subject crossover study where each participant is exposed to 4 conditions in random and sequential order: (A) Placebo, oral liquid; (B) Tetrahydrocannabinol (THC) only (20mg daily), oral liquid; (C) Tetrahydrocannabinol (THC) - Cannabidiol (CBD) (20mg-400mg), oral liquid and (D) Cannabidiol (CBD) only (400mg), oral liquid. Each participant will be exposed to two weeks of study medication per condition, with a one-week washout period between conditions, resulting in a 12-week trial duration for each participant. Outcomes will be assessed during the second week of medication for each condition using Ecological Momentary Assessment (EMA) and conventional data collection methods. Adherence to study intervention will be assessed using EMA and during research interviews.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18-65 years; 2. Chronic low back pain (CLBP) for more than 3 months, and with an average pain severity of over 4 on a 0-10 numeric rating scale in the previous month, and no treatable specific somatic cause for CLBP identified (e.g. herniated vertebral disk) based on a detailed medical history assessment and a clinical examination. The presence of a neuropathic pain component at baseline will be assessed using the painDETECT questionnaire with a cut-off score over 18. 3. Current dependence (ICD-11) to prescribed opioid medications (e.g. morphine, tapentadol, oxycodone, methadone, buprenorphine). 4. Prescribed and using a stable daily dose of oral morphine equivalent (OME) dose over 40mg within the preceding 28 days; with no more than 20 percent dose variation in past 4 weeks and no expected changes in opioid dose in the expected study period. 5. Stable use of other medications (e.g., antidepressants, NSAIDs) within the past 28 days, with no expected medication changes during the study period; 6. Willing to refrain from driving a motor vehicle for the duration of the study. 7. Participants of child-bearing potential are willing to use reliable contraception during the study. 8. Willing to avoid non-trial supplied cannabis products (illicit or prescribed) during the study. 9. Able and willing to provide written informed consent to the study procedures.
Exclusion criteria
1. Regular use of cannabis products (illicit or prescribed THC or CBD) in preceding 28 days, defined as using cannabis at frequency of more than once a week in the preceding month. Operationalised through self-report and the ability to provide a cannabis negative Urine Drug Screen (UDS) during the screening period (which indicates abstinence from cannabis use for approximately 1 week in a non-regular user) during screening. 2. Regular use of illicit opioids (e.g. heroin or illicitly obtained pharmaceutical opioids) in the preceding 28 days – defined as using illicit opioids at a frequency of more than once a week in the preceding month. Operationalised through self-report and the ability to provide an opioid negative UDS during the screening period for opioids other than those prescribed. 3. Active medical or psychiatric condition that in the opinion of the Study Medical Officer (SMO) would pose a safety risk or interfere with the interpretation of study data, including severe psychiatric disorders (mood, psychosis, anxiety), other substance use disorders (e.g. stimulants, benzodiazepines, alcohol), other chronic pain conditions (other than CLBP), or physical health conditions (e.g. cardiovascular conditions, severe hepatic disease (transaminases over 3 times, bilirubin over 2 times upper normal limits); history of cannabis-induced psychosis. 4. Risk of clinically significant drug-drug interactions (DDI) with CBD (mediated by CYP-450 (3A4, 2C19; CYP2B6, CYP2C9 metabolic pathways). The potential range of drug-drug interactions are considerable, and the SMO will make an assessment whether the potential for DDI is clinically significant (e.g., as for medications such as warfarin, HIV or anticonvulsant medications), and the SMO can discuss with PI Lintzeris if uncertain. 5. Not available during study period (e.g., travel, impending imprisonment). 6. Pregnant (assessed using urine beta hCG test) or breastfeeding; 7. Received an investigational medicinal product within the last 4 weeks.
Outcome results
None listed