None listed
Conditions
Brief summary
Background: Approximately half of all spinal cord injury patients develop chronic pain. Current treatments for this pain have proven to be largely ineffective and many have significant side-effects. We will examine whether a novel non-intoxicating component of cannabis, cannabidiol (CBD), can reduce pain. Using modern brain imaging techniques, we aim to determine if pain reductions result from normalisation of brain, immune, psychological and sleep function. In addition, we aim to identify a biomarker that will predict whether an individual will respond to CBD treatment, easing suffering, saving time and reducing costs. Study Aim: To determine the impact of CBD treatment on chronic pain following SCI and to investigate biological changes associated with reduced pain. Hypothesis: We hypothesise that CBD treatment will reduce ongoing pain to a significantly greater degree than placebo. Furthermore, we hypothesize that pain relief during CBD treatment will be associated with reduced diffusivity markers of astrogliosis, reduced resting infra-slow oscillations in the ascending pain pathway, restored thalamic blood flow to control levels and reduced thalamocortical rhythm power. We also hypothesize that CBD treatment will reduce ongoing peripheral inflammatory markers, improve sleep and psychological state and that this will correlate with a reduction in ongoing pain. Finally, we hypothesize that pain relief during CBD treatment will be associated with pre-trial levels of endogenous pain modulatory ability and endocannabinoid levels.
Interventions
This is a randomised, double-blinded, placebo-controlled, crossover, pilot trial assessing the effects of cannabidiol (CBD) in patients with chronic pain following spinal cord injury. The investigational product is an orally administered soft gel capsule containing 200 mg CBD isolate.
Eligible participants will be randomised to receive either 6-weeks of treatment with CBD or 6-weeks of treatment with matched placebo, with a 4-week washout period. Allocation to treatment group will be randomise
This is a randomised, double-blinded, placebo-controlled, crossover, pilot trial assessing the effects of cannabidiol (CBD) in patients with chronic pain following spinal cord injury. The investigational product is an orally administered soft gel capsule containing 200 mg CBD isolate. Eligible participants will be randomised to receive either 6-weeks of treatment with CBD or 6-weeks of treatment with matched placebo, with a 4-week washout period. Allocation to treatment group will be randomised and blinded for both participants and study personnel. Treatment Group A (Cannabidiol) Participants will administer CBD on a fixed schedule starting with 200 mg/day (one capsule) on Day 1-4; 400 mg/day (two capsules) from Day 5-8; 600 mg/day (three capsules) on Day 9-12); 800 mg/day (four capsules) from Day 13 until end of Week 6. Participants will be required to return all used and/or any unused bottles of medication to the study site pharmacy. Compliance with the study medication will be reviewed by the clinical trial pharmacy staff at the end of each treatment arm.
Sponsors
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 No maximum
Healthy volunteers
No
Inclusion criteria
(a) Complete or incomplete spinal cord injury as determined using the ASIA scale; (b) Below-level neuropathic pain for minimum 3 months duration; (c) Adult (18 years and over) who is able to provide informed consent; and (d) Proficient in English (must not require an English translator)
Exclusion criteria
(a) Spinal cord injury in acute stage of recovery (<12 months post-acute spinal cord injury or at the medical doctor’s discretion); (b) If on pain relieving medications must be on stable dose for at least 6 weeks prior to beginning our trial. This includes all prescription medications for pain including opioids or adjuvant pain medications such as Pregabalin, Amitriptyline and SSRIs. Paracetamol and over-the-counter NSAIDs (e.g., ibuprofen, aspirin, naproxen) within the recommended adult dosage permitted as needed. If there has been recent dose titration then we would wait for a stable 6-week period before entering the individual into the trial. (c) If on pain relieving medications, they must not be changed in dosage during the trial period; (d) Cannabis or any other drug or alcohol dependence, as per the International Statistical Classification of Diseases 10th Revision (ICD)-10 criteria or at a medical doctor’s discretion; (e) Reported use of cannabis within the past 3 months (or at the medical officer’s discretion); (f) Urine drug test positive for drugs (cannabis – THC only, meth/amphetamines, and cocaine) at each visit; (g) A history of (self-reported) allergic reaction (e.g. rhinitis, urticaria, contact dermatitis, anaphylaxis) to cannabis, cannabis products or cannabinoids; (h) A history of (self-reported) a clinically significant adverse response to CBD; (i) A history of moderate-to-severe hepatic impairment as determined by the medical doctor; (j) Use of medication(s) that may influence CBD metabolism (e.g. inducers or inhibitors of the CYP450 enzyme system) as determined by the medical doctor; (k) Unable to undergo MRI brain imaging as identified via 'NeuRA MRI Safety Screening Questionnaire'; (l) A history of a major psychiatric disorder within the previous 12 months except for clinically managed mild anxiety and/or depression as determined via clinical interview using the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria or at the medical doctor’s discretion; (m) Current suicide ideation as determined via clinical interview with the medical doctor; (n) Pregnancy or lactation - women shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed where necessary; (o) Patients with quadriplegia secondary to cervical spine injury.
Outcome results
None listed