Not Yet RecruitingPhase 2ACTRN12614000622606

Pilot Trial Proposal looking at the use of Cannabinoids for analgesia in chronic myocardial ischaemic chest pain, using Sativex Oromucosal Spray

In a patient with chronic ischaemic chest pain, will Sativex Oromucosal Spray reduce their pain

Sponsor

Dr Adrian Owen

Enrollment

10 participants

Start Date

Jul 1, 2014

Study Type

Interventional

Conditions

Chronic Ischaemic Chest Pain

Summary

Currently treatment for patients with longstanding chest pain caused by blockage of the blood supply to the heart is often ineffective. This trial will be to see if a spray under the tongue of a cannabis extract will help to relieve their pain. It is already used for chronic pain associated with cancer.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

In this initial trial the treatment group will be patients admitted to Waikato Hospital Emergency Department or Cardiology department, who are known to suffer from intractable coronary disease

Exclusion Criteria3

– Hypersensitivity to cannabinoids
– History of Schizophrenia
– Pregnant or breast feeding mothers

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

In this initial trial the treatment group will be patients admitted to Waikato Hospital Emergency Department or Cardiology department, who are known to suffer from intractable coronary disease. They

In this initial trial the treatment group will be patients admitted to Waikato Hospital Emergency Department or Cardiology department, who are known to suffer from intractable coronary disease. They will score their pain from 1-10 on a Numeric Rating Scale (NRS) and be given a single oromucosal spray dose of Sativex up to every 4 hours for a max of 5 days their NRS pain score will then be recorded one hour after receiving the dose. Each 100 microlitre Sativex spray contains: 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Each ml contains: 38-44 mg and 35-42 mg of two extracts (as soft extracts) from Cannabis sativa L., folium cum flore (Cannabis leaf and flower) corresponding to 27 mg delta-9-tetrahydrocannabinol and 25 mg cannabidiol. Extraction solvent: Liquid carbon dioxide. Excipient(s) with known effect: each 100 microlitre spray also contains up to 0.04 g ethanol.

Locations(1)

Waikato, New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614000622606