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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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000622606
Enrollment
10
Registered
2014-06-11
Start date
2014-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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-te

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.

Sponsors

Dr Adrian Owen
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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 criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026