Beat are assisting Opiant and MAC with research into the effects of intranasal naloxone on eating behaviours in bulimia nervosa.
We are looking for women with bulimia nervosa who would be interested in trying a new treatment. This study is looking to see if a nasal spray containing a well-known drug (naloxone hydrochloride) can help with the symptoms of bulimia nervosa.
Naloxone hydrochloride nasal spray is being developed for treating eating behaviours in patients with bulimia nervosa. The aim of this study is to find out how well the nasal spray affects binging and eating behaviours in patients with bulimia nervosa.
Female participants aged 18-60, fluent in English, who have a current diagnosis of bulimia nervosa and must:
Eligibility will be fully assessed by the hospital team.
|Avon & Wiltshire||Jo Morris|
|Barnet, Enfield & Haringey||Betselot Mulugeta|
|Black Country||Research & Innovation team|
|Dudley & Walsall||Florence Okwu|
|North West||NWBH Research Department|
|South London & Maudsley||Monica Leslie|
Full details will be available on the participant information sheet that you will be sent following discussion with the hospital team if you meet basic criteria.
If you are interested in taking part, a member of the research team will be in touch by phone to discuss the study.
If you meet basic eligibility criteria, you will be invited to visit a clinic. During the study, you will need to attend the clinic on four occasions for between 2 and 5 hours, over a 12-week period.
On the first visit, it will be determined if it is appropriate for you to participate in the study. If you are happy to continue you will be asked to sign consent forms, one of which is for you to keep. Please note: participation in this study requires the answer to survey questions about your weight and measurements of your weight and height.
The study includes a 2-week screening period where you will be asked to complete some brief questions on your eating behaviours in an electronic diary every day. If you are suitable for the study you will receive either a nasal spray of naloxone or matching placebo. A placebo is a ‘dummy treatment’, which looks like the genuine medicine but contains no active ingredient. You will have an equal chance of being allocated one of the two treatments which is decided by a computer. You should take your allocated treatment as instructed and complete the electronic diary every day for the 8-week treatment period.
During the visits, you will be asked to undergo physical examination, drug test, pregnancy test, blood test, smell test and complete a series of questionnaires. On two of the visits there will be a ‘taste test’ during which participants will rate the flavours of four different types of food.
After the treatment period, there will be a 2-week follow-up phase to ensure there are no safety issues after you have finished taking the product.
Participants will be reimbursed up to £130 (store vouchers) for their time.