Pilot Study: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group A
max 8 mg/per day naloxone nasal spray
干预措施: Naloxone hydrochloride 20mg/ml (Drug)
Group B
max 16 mg/per day naloxone nasal spray
干预措施: Naloxone hydrochloride 20mg/ml (Drug)
结局指标
主要结局
Adverse events
时间窗: 8 weeks
Diary
Adherence
时间窗: 8 weeks
Case Report Form
次要结局
- Gambling expenditure(8 weeks)
研究者
Hannu Alho
Research Professor
Finnish Institute for Health and Welfare