Gambling, Naloxone, Opioid, Spray
Conditions
Keywords
antagonist, nasal
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.
Interventions
DRUGNaloxone hydrochloride 20mg/ml
Nasal spray
Sponsors
Finnish Institute for Health and Welfare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Group A: max 8 mg/per day naloxone nasal spray Group B: max 16 mg/per day naloxone nasal spray
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 8 weeks | Diary |
| Adherence | 8 weeks | Case Report Form |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gambling expenditure | 8 weeks | Money |
Countries
Finland
Outcome results
None listed