Effects of intranasal naltrexone on alcohol use disorder
Research type
Research Study
Full title
Randomised, double-blind, placebo-controlled trial evaluating the effects of naltrexone hydrochloride nasal spray on alcohol consumption in Alcohol Use Disorder
IRAS ID
270913
Contact name
Christos Kouimtsidis
Contact email
Sponsor organisation
Opiant Pharmaceuticals Inc
Eudract number
2019-002859-42
Duration of Study in the UK
1 years, 2 months, 29 days
Research summary
In England, there are an estimated 589,101 dependent drinkers (2016/17), of whom 81.7% are not accessing treatment (Public Health England, 2017). Alcohol misuse is the biggest risk factor for death, ill-health and disability among 15-49 year-olds in the UK, and the fifth biggest risk factor across all ages (Public Health England, 2016).
Naltrexone is a drug used to manage alcohol use disorder and has been shown to reduce alcohol consumption in clinical studies. Currently, it can be taken as a daily tablet or given as an injection lasting 4 weeks. If taken as a nasal spray, it is expected to work faster and therefore could be used ‘as needed’ to help reduce cravings for alcohol.
This phase II study will test the effect of using a daily naltrexone nasal spray for 16 weeks, with the option of taking a second dose daily as needed. The study is randomised, double-blind and placebo-controlled to eliminate bias in selecting and evaluating patients. The safety of naltrexone as a nasal spray and the placebo control, used over 16 weeks, will also be assessed.This study will enrol 300 patients, male and female, between 18 and 70 years old, diagnosed with alcohol use disorder. Patients will be found from clinics based at different locations across the UK and EU.
The study will last for 21 weeks, including a 1 week screening phase, 16 week treatment phase and 4 week follow-up phase. Patients will visit the clinic on 12 occasions, a maximum of 2 weeks apart. Patients will also be contacted by phone at week 9 to check on their wellbeing. During the clinic visits, assessments will include physical examination, vital signs, urine, breath and blood tests, questionnaires, smell test and a self-help program.
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1893
Date of REC Opinion
28 Jan 2020
REC opinion
Further Information Favourable Opinion