Investigating the effects of a cannabis-based medication on sleep problems in chronic pai

Phase 3

• Conditions: Insomnia; Anaesthesiology - Pain management; Neurological - Other neurological disorders; Chronic Pain

• Registration Number: ACTRN12623000870651
• Lead Sponsor: IVERSITY OF AUCKLAND

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Already a patient in the Bay of Plenty chronic pain services
•Chronic back pain without evidence of radiculopathy or a serious underlying disease
•Age:25-85
•Pain score >4 on Numerical Rating Scale (NRS)at baseline visit
•Insomnia Severity Index (ISI) score >14 at baseline visit
•Treatment regimen for pain or insomnia stable for three months before baseline

Exclusion Criteria

•Current use of cannabis products
•History of significant mental illness, alcohol, or drug abuse
•Untreated cardiovascular or metabolic disorders, renal or hepatic impairment
•Other significant sleep disorders
•Pregnancy
•Use of medication which can interact with IMP
•Use of new pain or insomnia treatments during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index Score (ISI)[ At baseline (before treatment) and then at seven day intervals until 84 days after starting treatment in each leg of crossover study.]