Pathological Gambling Clinical Trial
— NalGambOfficial title:
Double-blind, Placebo-controlled Randomised Study on the Efficacy of Naloxone Nasal Spray for the Treatment of Gambling Disorder
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
Status | Not yet recruiting |
Enrollment | 126 |
Est. completion date | November 30, 2018 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute for Health and Welfare, Finland | Opiant Pharmaceuticals |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number and proportion of subjects with adverse events | The use of the daily questionnaire / telephone operated (text messages) diary (daily use of sprays, number of doses, gambling expenditure and frequency and possible adverse events) and self-administration of IMP. | Baseline to week 12 - daily | |
Other | Assessment of clinical laboratory parameters | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, and 12 laboratory parameters will be assessed. | Baseline to Week 12 | |
Other | Assessment of vital signs | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6 and 12 vital signs will be assessed. | Baseline to Week 6 and 12 | |
Other | Assessment of physical examination | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6, and 12 physical examination. | Baseline to Week 6 and 12 | |
Other | Assessment of body weight | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6, and 12 body weight will be assessed. | Baseline to Week 6 and 12 | |
Other | Assessment of examination of nasal mucosa | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6, and 12 nasal mucosa will be assessed. | Baseline to Week 6 and 12 | |
Other | Assessment of smell test | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline and week 12 smell will be assessed. | Baseline to Week 12 | |
Primary | The Gambling Symptom Assessment Scale (GAS) change is being assessed | Gambling symptoms (G-SAS) from Baseline to week 3, 6, 9, and week 12 | Gambling symptoms (G-SAS) from Baseline to week, 3, 6, 9 and week 12. | |
Secondary | VAS (gambling graving) | The entire study for an individual participant will last 12 + 1 weeks. Every weeks from baseline, 3,6,9,and 12 graving of gambling will be assessed. | from Baseline to Week 3, 6, 9 and 12 | |
Secondary | Gambling severity (PGSI) | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6, and 12 severity of gambling will be assessed. | Baseline to Week 6 and 12 | |
Secondary | Gambling severity (DSM-5) | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6, and 12 severity of gambling will be assessed. | from Baseline to Week 6 and 12 | |
Secondary | Gambling problems (NODS) | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 3,6,9,and 12 level of gambling problems will be assessed. | Baseline to Week 3, 6, 9 and 12 | |
Secondary | Gambling expenditure and frequency | daily questionnaire / telephone operated (text messages) diary (daily use of sprays, number of doses, gambling expenditure and frequency and possible adverse events) and self-administration of IMP. | Baseline to Week 12 | |
Secondary | Abstinence of gambling (GASS) | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 3,6,9,and 12 abstinence of gambling will be assessed. | Baseline to Week 3, 6, 9 and 12 | |
Secondary | Internet use (Internet disorder scale-9 short form) | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6, and 12 internet use will be assessed. | Baseline to Week 6 and 12 | |
Secondary | Quality of life (WHO: EUROHIS-8) | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6, and 12 quality of life will be assessed. | Baseline to Week 6 and 12 | |
Secondary | Alcohol consumption (AUDIT) | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6, and 12 graving of gambling will be assessed. | Baseline to Week 6 and 12 | |
Secondary | Depression (MADRS) | The entire study for an individual participant will last 12 + 1 weeks. Every week from baseline, 6, and 12 mood will be assessed. | Baseline to Week 6 and 12 |
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