Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
Phase 2
Completed
- Conditions
- NaloxoneSprayGamblingOpioid
- Interventions
- Registration Number
- NCT03223896
- Lead Sponsor
- Finnish Institute for Health and Welfare
- Brief Summary
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. Brief intervention.
- Detailed Description
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. No supportive therapy, but brief self-help booklet. Primary outcomes: adverse events, adherence and drop out analysis. Secondary outcome: gambling expenditure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- age over 18 years old
- South Oaks Gambling Scale (SOGS) 5 or over points
- possibility to keep a record with phone and send text messages
- fluent in Finnish Language
Exclusion Criteria
- active drug use (specially opioids) current use - drugs screen
- nasal abnormality or mucosal irritability
- hepatitis c virus, kidney insufficiency
- psychosis, unstable mental health, risk suicide (Beck Depression Inventory)
- pregnancy and/or breast feeding
- persons according to Finnish Medical Law 188/1999 §7-10
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Naloxone hydrochloride 20mg/ml max 16 mg/per day naloxone nasal spray Group A Naloxone hydrochloride 20mg/ml max 8 mg/per day naloxone nasal spray
- Primary Outcome Measures
Name Time Method Adherence 8 weeks Case Report Form
Adverse events 8 weeks Diary
- Secondary Outcome Measures
Name Time Method Gambling expenditure 8 weeks Money
Trial Locations
- Locations (1)
National Institute for Heath and Welfare
🇫🇮Helsinki, Finland