Pathological Gambling, Gambling Disorder, Opioid Antagonist, Naloxone
Conditions
Brief 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
Detailed description
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Finnish Institute for Health and Welfare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double Blind
Intervention model description
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. One spray of naloxone hydrochloride 40mg/ml nasal spray contains 4 mg naloxone hydrochloride in a formulation of benzalkonium chloride, sodium edetate, sodium chloride, hydrochloric acid and purified water. 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. One spray of placebo nasal spray contains benzalkonium chloride, sodium edetate, sodium chloride, hydrochloric acid and purified water
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Gambling Symptom Assessment Scale (G-SAS) gambling symptom severity and change during the treatment - assessment | Baseline to week, 3, 6, 9 and week 12. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gambling severity (PGSI) | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 severity of gambling will be assessed. |
| Gambling severity (DSM-5) | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. From baseline to week 6, and 12 severity of gambling will be assessed. |
| Gambling expenditure and frequency | Baseline to Week 12 | 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. |
| Abstinence of gambling (GASS) | Baseline to Week 3, 6, 9 and 12 | 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. |
| Internet use (Internet disorder scale-9 short form) | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 internet use will be assessed. |
| Quality of life (WHO: EUROHIS-8) | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 quality of life will be assessed. |
| Alcohol consumption (AUDIT) | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 graving of gambling will be assessed. |
| Depression (MADRS) | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 mood will be assessed. |
| Gambling problems (NODS) | Baseline to Week 3, 6, 9 and 12 | 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. |
| VAS (gambling craving) | Baseline to Week 3, 6, 9 and 12 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of vital signs - blood pressure, pulse, temperature | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. Assessments at baseline, 6 and 12 vital signs ( blood pressure, pulse and temperature) will be assessed. |
| Assessment of body height | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. Assessments at the baseline, week 6, and week 12. Body height will be assessed. |
| Assessment of body weight | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. Assessment at baseline, 6, and 12 . Body weight will be assessed. |
| Assessment and examination of nasal mucosa | Baseline to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. Assessment at baseline, 6, and 12 nasal mucosa will be assessed using Nasal Irritation Scale (0= normal appearing mucosa, no bleeding to 5= Ulcerated lesions, bleeding with requires medical intervention). Assessment is performed by MD. |
| Assessment of smell test | Baseline to Week 12 | The entire study for an individual participant will last 12 weeks. Assessments at baseline and week 12 smell will be assessed.Smell test will be conducted at Baseline and Week 12. NIH Toolbox Odour Identification Test: This validated smell identification test uses 'scratch and sniff' technology, and pictures for the multiple-choice options of 9 common smells. It is intended for a rapid research assessment of olfactory ability. |
| Number and proportion of subjects with adverse events | Baseline to week 12 - daily | 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. |
| Assessment of clinical laboratory parameters - Pregnancy test | Screening to Week 6 and 12 | The entire study for an individual participant will last 12 weeks. At Screening and week 12 blood pregnancy test and week 6 urine pregnancy test |
Countries
Finland
Outcome results
None listed