Randomised, double-blind, placebo controlled trial evaluating the effects of naloxone hydrochloride nasal spray on eating behaviours in bulimia nervosa

Phase 1

Active, not recruiting

• Conditions: Bulimia nervosa; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]; MedDRA version: 20.0 Level: PT Classification code 10006550 Term: Bulimia nervosa System Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2016-003107-65-GB
• Lead Sponsor: Opiant Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 82

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified