Buccal naloxone testing in healthy volunteers (NalBuc)
Research type
Research Study
Full title
Ultra-portable rapid-dispersal buccal lyophilised naloxone for constant carriage: testing in healthy volunteers
IRAS ID
1011060
Contact name
John Strang
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN67173532
Research summary
This study addresses whether a novel ultra-portable buccal naloxone wafer can provide rapid drug absorption comparable to current naloxone formulations, improving emergency overdose response through better medication carriage and availability.
Naloxone saves lives. As emergency antidote medication, it rapidly reverses heroin/opioid overdose, preventing drug-related death, but only if administered promptly at time of crisis. Deaths can occur before arrival of emergency services: so naloxone is now pre-provided to friends and families and those with active addiction problems (plus frontline staff, outreach workers, hostel staff, police officers). Naloxone has historically been provided as pre-filled syringe for injection or, recently, as nasal spray.
But there are problems with these forms of naloxone (injection, nasal). With nasal naloxone, people need healthy nasal passages and no mucus/vomit. Naloxone also needs to be there, on their person, when the unanticipated future emergency occurs. We need a format as portable as a wallet or mobile phone (hopefully never needed, but there, just in case).
Our feasibility work demonstrated that rapid-dispersal naloxone wafers can be produced, disintegrating within seconds. These will fit into wallet or purse, thereby remedying current poor carriage rates for naloxone (only 15-20%). These now need testing on the mucosa inside the mouth (in the cheek cavity).
We propose to study absorption of different versions of naloxone in healthy volunteers aged 18-60 years at King's College Hospital Clinical Research Facility. Participants will undergo 5 experimental visits over 3 weeks with intensive blood sampling to compare this new buccal wafer versus current forms of naloxone for speed of absorption and optimal dosing. This research is funded by The Scottish Chief Scientist's Office, NHS Fife and Health Innovation South East Scotland (HISES).REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0701
Date of REC Opinion
28 Oct 2025
REC opinion
Further Information Favourable Opinion