Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention - a Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PG-YBOCS.
研究概览
简要总结
The aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as combined with CBT-intervention in the treatment of pathological gambling (PG). The study period is 2011-2014 during which one hundred Pathological Gamblers will be recruited to participate to this placebo-controlled double-blind trial.
详细描述
All participants have to be able to read and understand the patient information sheet and sign the informed consent. All participants are free to stop being in the study whenever they wanted. The patients are not paid or reimbursed for participation.
The study periods is 21 weeks during which the participant's have 8 appointments with the researchers. During the meetings research data will be collected and the participant is having Controlled Behavioral Therapy (CBT) consulting from a trained therapist. At the study visits, the subjects are given written instructions for the proper use of naltrexone and advised to take 50 mg naltrexone approximately one hour before gambling or feeling urges to gamble (and to refrain from taking naltrexone at other times). In this study the maximal daily dose is 50mg of naltrexone. The medication is free for the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological gambling (scores 5+ from SOGS-R and DSM-IV criteria)
排除标准
- •acute hepatitis
- •severe liver or kidney dysfunction
- •suicide risk or severe depression or other untreated mental health problem
- •participation to other gambling research at the same time
- •the use of drugs (especially opiates)
- •pregnancy
- •prisoners
- •retarded and mentally ill patients were also excluded
研究组 & 干预措施
Placebo pill.
干预措施: Placebo (Drug)
50mg Naltrexone when needed
干预措施: Naltrexone pharmacotherapy (Drug)
结局指标
主要结局
PG-YBOCS.
时间窗: Up to 21 weeks.
The investigators will interview PG-YBOCS questionnaire from the participants.
次要结局
- Alcohol use.(Up to 21 weeks.)
- Quality of life.(Up to 21 weeks.)
研究者
Hannu Alho
Professor
Finnish Institute for Health and Welfare