Effects of intranasal naloxone on eating behaviours in bulimia nervosa
Research type
Research Study
Full title
Randomised, double-blind, placebo controlled trial evaluating the effects of naloxone hydrochloride nasal spray on eating behaviours in bulimia nervosa
IRAS ID
212826
Contact name
Treasure Janet
Contact email
Sponsor organisation
Opiant Pharmaceuticals Inc
Eudract number
2016-003107-65
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
In eating disorders such as bulimia nervosa and binge eating disorder, drugs that block the action of opiates such as naltrexone, naloxone and nalmefene have been shown to reduce the tastiness of food, preference for sweet/high fat “binge-type” foods, the pleasure of eating foods, meal length and meal intake, in particular for binge eaters.
This Phase II study will explore the effects of naloxone hydrochloride nasal spray on eating behaviours in bulimia nervosa. The study is randomised, double blind and placebo controlled to eliminate bias in selecting and evaluating the patients. The aim of this study is to find out how well the naloxone nasal spray affects binging and eating behaviours including risk taking and control of risks in patients with bulimia nervosa.
The study will enrol 82 female patients, aged 18 to 60, diagnosed with bulimia nervosa from eight eating disorder clinics based in England.
The study will last for 12 weeks during which time the patients will attend the clinic on four occasions and be contacted by phone once during the trial. Clinic visits will be at Screening, Baseline, 4 weeks and then 8 weeks. Patients will take one spray of naloxone hydrochloride (4mg) or placebo, in one nostril, every day, plus additional doses as needed in response to binging urges up to 3 more times per day from baseline to week 8. Patients will have an equal chance of receiving naloxone hydrochloride or placebo spray. Patients will complete an electronic diary on a daily basis from screening to week 8. Assessments at clinic visit will include physical and nasal examination, vital signs, weight, height, routine blood tests, pregnancy and opioid drug tests, taste and smell tests, risk and attention tests and questionnaires.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/1820
Date of REC Opinion
21 Nov 2016
REC opinion
Further Information Favourable Opinion