Unblinding in the Octopus trial
Octopus is a double-blind trial. This means that neither the participant nor their doctors will know which treatment they have received.
Participants in the Octopus trial take up to a total daily amount of 2000mg (4 capsules) of Immediate Release Metformin or 1200mg (4 capsules) of R/S-Alpha Lipoic Acid or 4 capsules of Placebo.
We only expect unblinding in Octopus trial in rare clinical circumstances. For example, when knowledge of treatment allocation is essential to guide clinical management.
For specific anticipated scenarios with advice to unblind, read this guidance on unblinding clinical scenarios.
If unblinding is needed, all NHS doctors are able to find out a participant’s allocation through the unblinding process. When unblinding is being considered, is should first be discussed either with the trial team at the recruiting hospital, or with the Octopus team (Chief Investigator, Prof Jeremy Chataway or Octopus Clinical fellow(s)). All details are found on the participant’s Octopus trial card. However, if unblinding is essential for the participant’s immediate management, please proceed to unblind the participant.
You can find out about the unblinding process in this flow diagram.
If you have any questions, please refer to the participation card for local site contact details or out of hours numbers.
To contact the Octopus team:
- Phone: UCLH out of hours emergency number +44 (0)20 3456 7890
- Please ask for Prof. Jeremy Chataway, Dr Sean Apap Mangion or Dr Charles Wade
- Email: mrcctu.octopus@ucl.ac.uk (working hours only)
All NHS doctors can directly access treatment information in an emergency using the link below and entering their GMC number and NHS email address in addition to the participant’s ID number and date of birth. The participant’s ID number can be found on their Octopus participation card. Unblinding details will be sent to the NHS email address provided.
UNBLINDING SHOULD ONLY BE PERFORMED BY AN NHS DOCTOR AND SHOULD ONLY BE CONSIDERED WHERE KNOWLEDGE OF TREATMENT ALLOCATION IS ESSENTIAL TO GUIDE CLINICAL MANAGEMENT.
