Overview

Effects of Intranasal Naloxone on Gambling Urges in Gambling Disorder

Status:
Not yet recruiting
Trial end date:
0000-00-00
Target enrollment:
126
Participant gender:
All
Summary
Primary objective: *To determine whether treatment with naloxone hydrochloride nasal spray reduces gambling urge symptoms in patients with gambling disorder The secondary objectives of the study are: - To determine the effects of naloxone hydrochloride nasal spray on gambling severity, frequency and time, internet use, self-efficacy, quality of life, alcohol consumption, depression - To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of gambling disorder
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Institute for Health and Welfare, Finland
Collaborator:
Opiant Pharmaceuticals
Treatments:
Naloxone
Last Updated:
2017-09-12
Criteria
Inclusion Criteria:

- Inclusion criteria:

The Subject must satisfy the following criteria for entry into the study:

1. Aged 18 to 75 years, fluent in Finnish and able to read and understand the patient
information sheet

2. Provide written, informed consent prior to any study specific procedure being
conducted

3. Gambling problem at pre-screening (SOGS 5 or more points)

4. Moderate (6-7 criteria met) or severe (8-9 criteria met) GD (DSM-5) assessed by
clinical interview with Medical Doctor (MD)

5. At least 4 weeks since completion of any other previous treatment for GD

6. At least 8 weeks since completion of any previous treatment with naltrexone or
nalmefene

7. Willingness to comply with all study procedures and visit schedules

Exclusion Criteria:

- Exclusion criteria:

The Subject will be excluded from the study if any of the following applies:

1. Two weeks or longer abstinence from gambling prior to randomisation

2. Known allergic reactions to naloxone or excipients of IMP and placebo

3. Current use of drugs (opiates, amphetamine, metamphetamine, cocaine, cannabis and
benzodiazepines) (as assessed by saliva drug screen, DrugWipe-6)

4. Subject is taking any prohibited medication (opioid analgesics, any medication
delivered to the nose)

5. Serious mental illness or severe Depression assessed by Structured Clinical Interview
for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Disorders
(SCID-I, DSM-5) and the Montgomery and Asberg Depression Rating Scale (MADRS) scores
24 points or more

6. Clinically significant risk of suicide (Columbia-Suicide Severity Rating Scale
(C-SSRC))

7. Women who are pregnant or breastfeeding at screening or Baseline

8. Serious kidney (P-Creatinine > 110 umol/ml) insufficiency

9. The Subject/patient, in the opinion of the investigator, is unlikely to comply with
the clinical study protocol or is unsuitable for any reason.

10. Liver cirrhosis or liver enzyme elevations, ASAT or ALAT >200 (by blood drop test),

11. Active HCV infection (saliva test, OralQuick-HCV)

12. The person that met the criteria of vulnerable person according to Finnish Medical
Research Act No188/1999 7-10ยง

13. Women of childbearing potential, defined as all women physiologically capable of
becoming pregnant, unless surgically sterile must use effective contraception (either
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 (only considered an acceptable method of contraception when
it is in line with the subjects' usual and preferred lifestyle), 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
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.

14. Severe comorbidity (e.g., drug addiction, psychosis, diabetes)

15. Experimental agents must have been discontinued at least 8 weeks prior to screening
for a period equivalent to 5 half-lives of the agent (whichever is longer)

16. Any diagnosed nasal conditions including abnormal nasal anatomy, nasal symptoms (i.e.
blocked nose, nasal polyps etc.), or having product sprayed in to the nasal cavity
prior to drug administration

17. Subject with concurrent disease considered by the investigator to be clinically
significant in the context of the study.