Bulimia nervosa MedDRA version: 20.0 Level: PT Classification code 10006550 Term: Bulimia nervosa System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Naloxone hydrochloride 40mg/ml nasal spray
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: naloxone hydrochloride
CAS Numb
Sponsors
Opiant Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female aged 18 to 60 years, fluent in English, having provided written, informed consent prior to any study specific procedure being conducted 2. Diagnosis of bulimia nervosa according to Diagnostic and Statistical Manual of Mental Illness’s (5th Edition) criteria by The Structured Clinical Interview for the DSM-5- Research Version (SCID-RV) prior to screening 3. Subjects reporting at least one binging day per week during screening Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 82 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Severe comorbidity (e.g., substance abuse, drug addiction, psychosis, diabetes) 2. Previous (in the last 12 months) or current opioid, alcohol, or other drug dependence (excluding nicotine and caffeine), based on medical history prior to screening 3. Any history of neurological condition considered by the investigator to be clinically significant in the context of the study 4. Known allergic reaction to naloxone 5. Known allergic reaction to excipients of IMP and placebo 6. Subject is taking any prohibited medication (opioid analgesics, any medication delivered to the nose) 7. Opioids (unless discontinued at least 4 weeks prior to screening) 8. Any fluoxetine treatment (unless it has been administered at a stable dose for a minimum of 12 weeks prior to screening and remain at a stable dose throughout the trial) 9. Any cognitive behavioural therapy (CBT) or other behavioural therapies (unless it has been completed or has currently been receiving CBT or other behavioural therapies for more than 8 weeks prior to screening. No new CBT or other behavioural therapies started during the trial) 10. Experimental agents must have been discontinued at least 8 weeks prior to screening or a period equivalent to 5 half-lives of the agent (whichever is longer) 11. A significant visual impairment, which is not corrected by eyewear 12. Any nasal conditions including abnormal nasal anatomy, nasal symptoms (i.e. blocked and/or runny nose, nasal polyps etc.), or having product sprayed in to the nasal cavity prior to drug administration 13. Consume more than 21 units of alcohol per week (1 unit = 1/2 pint of beer (285mls) or 25ml of spirits or 1 glass of wine) (in the past 6 months prior to screening) 14. Positive urine drug test for opioids at screening or baseline 15. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile must use effective contraception (combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD], intrauterine hormone-releasing system [IUS], vasectomised partner, sexual abstinence, combination of male condom with either cap, diaphragm or sponge with spermicide [double barrier methods]), and willing and able to continue contraception for 1 month after the last administration of IMP. Women using oral contraception must have started using it at least 2 months prior to screening. Women are not considered to be of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels that have been confirmed to be in the “postmenopausal range”. Or have had a surgical bilateral oophorectomy (with or without hysterectomy) or bilateral tubal ligation at least six weeks before the screening visit. In case of oophorectomy alone, the reproductive status of the woman should have been confirmed by follow up hormone level assessment. 16. Women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 8;Main Objective: To assess if treatment with naloxone hydrochloride nasal spray reduces the binging behaviour in bulimia nervosa.;Primary end point(s): Number of binging days from baseline to Week 8.; Secondary Objective: To assess the effects of naloxone hydrochloride nasal spray on immediate eating behaviours. To assess the effects of naloxone hydrochloride nasal spray on eating behaviours. To assess the difference in the effects of naloxone hydrochloride nasal spray between a single dose compared to multiple doses. To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of bulimia nervosa. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of binging episodes from baseline to Week 8 • Abstinence of binging at Week 8 for at least a two week period • Purging behaviour at Week 8 • Total number of calories in the taste test at Week 8 • Total number of calories in the taste test at baseline • EDE-Q Week 8 • VAS (on mood, craving, hunger, anxiety, purging and feeling full) at Week 8 • FCQ at Week 8 ; Timepoint(s) of evaluation of this end point: • Number of binging episodes - Week 8 • Abstinence of binging at Week 8 for at least a two week period • Purging behaviour - Week 8 • Total number of calories in the taste test - Week 8 • Total number of calories in the taste test - baseline • EDE-Q - Week 8 • VAS (on mood, craving, hunger, anxiety, purging and feeling full)- Week 8 • FCQ - Week 8 | — |
Countries
United Kingdom
Contacts
Public ContactProject Manager
Opiant Pharmaceuticals UK Ltd
Outcome results
None listed