None listed
Conditions
Brief summary
The primary purpose of this study is to provide evidence for the efficacy and tolerability of a cannabis-based medication (Sativex) in the treatment of pain and overall symptom burden in patients with end stage renal disease.
Interventions
A battery of tests will be completed at the baseline assessment (following a 7 day run-in period), prior to the first dose of Sativex. This will include the modified Edmonton Symptom asse3ssment Scale that uses a 0-10 numerical rating scale (NRS) to assess 10 common symptoms, the Beck Depression inventory, the Brief Pain Inventory, the Pittsburgh Sleep Quality Index, and the Short Blessed Orientation-Memory-Concentration test. Vital signs will be recorded. Participants will then receive their
A battery of tests will be completed at the baseline assessment (following a 7 day run-in period), prior to the first dose of Sativex. This will include the modified Edmonton Symptom asse3ssment Scale that uses a 0-10 numerical rating scale (NRS) to assess 10 common symptoms, the Beck Depression inventory, the Brief Pain Inventory, the Pittsburgh Sleep Quality Index, and the Short Blessed Orientation-Memory-Concentration test. Vital signs will be recorded. Participants will then receive their first dose of Sativex and dosing instructions from the study nurse. The patients will then take the medication home with them for a 21 day treatment period. Sativex is a sublingual buccal spray. Dosing will start at 2 doses (sprays)/day and then be titrated by patients depending upon need. The study nurse will follow-up with the patient either while on dialysis or over the telephone at least every 2 days to review their doses, pain severity, and assess for any adverse effects of the drug. During the telephone follow-up, patients will be advised to optimize dosing when suboptimal benefit has been achieved (suboptimal being defined as = 4/10 on NRS or considered suboptimal by the patient). Patients will be asked to keep a daily log of pain scores, time and dose of study medication, time and use of any other analgesics.
Sponsors
Northern Alberta Renal Program
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. ESRD on chronic dialysis (greater than or equal to 3 months) 2. Moderate to severe daily pain (greater than or equal to 4 on 0-10 Numerical Rating Scale (NRS)) a. Receiving no opioids b. Receiving opioids (for at least 14 days prior to the screening visit) but pain not adequately relieved c. If receiving analgesics, no increase in analgesic dose for the past 14 days. 3. No cannabinoid use for at least 7 days before screening and during the course of the study 4. Stable dry weight for the past 2 weeks 5. Have given written, informed consent
Exclusion criteria
1. No history of myocardial infarction or stroke 2. > 3 of the last 6 post hemodialysis blood pressure readings greater than or equal to 160/100 mmHg (or mean arterial pressure (MAP) of 120 mmHg) 3. > 3 of the last 6 post hemodialysis blood pressure readings of greater than or equal to 100/55 mmHg (or MAP of 70) 4. History of psychosis or psychiatric disorder other than depression 5. History or suspicion of substance abuse 6. Cancer of the oral cavity 7. Scheduled procedures requiring general anesthesia during the study (4 weeks) 8. Taking levodopa or the immunosuppressives cyclosporine or tacrolimus 9. Known or suspected hypersensitivity to cannabinoids
Outcome results
None listed