Cannabis-Based Medicine (Sativex) in the Treatment of Pain in Kidney Failure

• Conditions: End stage renal disease; Chronic pain; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12610000783022
• Lead Sponsor: orthern Alberta Renal Program

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in mean numerical rating scale (NRS) pain score of 30% from baseline to end of study[21 days after start of intervention]