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
This is a 12 week, randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of naloxone hydrochloride nasal spray in gambling disorder. Anticipated number of participants are 126. Treatment Group A: Naloxone hydrochloride 40mg/ml nasal spray Naloxone hydrochloride will be dosed at 4mg / dose (one spray of 0.1ml of the 40mg/ml formulation into one nostril) up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks. Treatment Group B: Placebo nasal spray One spray of 0.1ml of the placebo formulation in one nostril up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks. Safety parameters: Study Subjects will be asked to report any changes in health via the daily questionnaire. This will be reviewed weekly and at each study Visit (including phone calls) and any adverse events will be documented in the eCRF. Changes in vital signs and outcome of routine blood analyses will be evaluated. Adverse events (AEs) will be classified using a coding thesaurus (MedDRA). Primary endpoint: Gambling symptoms (G-SAS) from Baseline to week 12. Gambling symptoms (G-SAS) from Baseline to week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
126
Naloxone hydrochloride will be dosed at 4mg / dose (one spray of 0.1ml of the 40mg/ml formulation into one nostril) up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.
One spray of 0.1ml of the placebo formulation in one nostril up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.
National Institute for Health and Welfare
Helsinki, Uusimaa, Finland
The Gambling Symptom Assessment Scale (G-SAS) gambling symptom severity and change during the treatment - assessment
The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. The G-SAS is not a diagnostic or screening instrument. Each 12-item scale has a score ranging from 0 - 4 (adjective anchors for 0 and 4 vary for each item). All items ask for an average symptom based on the past 7 days. Items 1 - 4 can be used to assess changes in craving symptoms. Total score ranges from 0 - 48: extreme = 41 - 48, severe = 31 - 40, moderate = 21 - 30, mild = 8 - 20.
Time frame: Baseline to week, 3, 6, 9 and week 12.
VAS (gambling craving)
The entire study for an individual participant will last 12 weeks. From baseline to weeks 3,6,9,and 12 craving of gambling will be assessed.
Time frame: Baseline to Week 3, 6, 9 and 12
Gambling severity (PGSI)
The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 severity of gambling will be assessed.
Time frame: Baseline to Week 6 and 12
Gambling severity (DSM-5)
The entire study for an individual participant will last 12 weeks. From baseline to week 6, and 12 severity of gambling will be assessed.
Time frame: Baseline to Week 6 and 12
Gambling problems (NODS)
The entire study for an individual participant will last 12 weeks. From baseline to weeks 3,6,9,and 12 level of gambling problems will be assessed.
Time frame: Baseline to Week 3, 6, 9 and 12
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.
Time frame: Baseline to Week 12
Abstinence of gambling (GASS)
The entire study for an individual participant will last 12 weeks. From baseline to weeks 3,6,9,and 12 abstinence of gambling will be assessed.
Time frame: Baseline to Week 3, 6, 9 and 12
Internet use (Internet disorder scale-9 short form)
The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 internet use will be assessed.
Time frame: Baseline to Week 6 and 12
Quality of life (WHO: EUROHIS-8)
The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 quality of life will be assessed.
Time frame: Baseline to Week 6 and 12
Alcohol consumption (AUDIT)
The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 graving of gambling will be assessed.
Time frame: Baseline to Week 6 and 12
Depression (MADRS)
The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 mood will be assessed.
Time frame: Baseline to Week 6 and 12
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