Naltrexone Treatment in Pathologic Gambling Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)
研究概览
简要总结
This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.
详细描述
PGD is a prominent and growing social problem. Unfortunately, there is no established drug treatment for this disorder. Preliminary investigations demonstrate that naltrexone in doses up to 250 mg/day is well tolerated and safe during an 11-week period and may be a viable treatment option for PGD patients with severe urges. The implications of this study extend from PGD to other impulse control disorders, including compulsive shopping, kleptomania, and possibly alcoholism.
Participants are randomly assigned to receive either naltrexone or placebo for 16 weeks. The responses of men and women are compared to determine whether efficacy is distributed in a male:female ratio analogous to that of the PGD population in the United States. A Clinical Global Impression and a Gambling Symptom Scale are used to assess participants.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic and Statistical Manual IV criteria for Pathological Gambling Disorder
- •Moderate or severe gambling urge assessed by the Gambling Symptom Assessment Scale
- •No psychiatric drug use for 2 weeks or more
- •Score >= 5 on The South Oaks Gambling Screen
- •Hamilton Depression Rating Scale and Anxiety Rating score <
- •An increase (up to 10 points) of the scores is allowed unless the subject shows the risks of suicide.
- •Completion of complete blood count, urinalysis, liver and thyroid function tests, and pregnancy tests, with no evidence of significant lab abnormalities
- •Reliable birth control in women of child-bearing potential
排除标准
- 未提供
研究组 & 干预措施
Naltrexone
17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.
干预措施: Naltrexone (Drug)
Placebo
Subjects who were assigned to placebo in the 17 week double-blind phase.
干预措施: Placebo (Drug)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)
时间窗: 18 weeks
A gambling severity measure derived from the Yale-Brown Obsessive Compulsive Scale. It sums gambling urges and thoughts questions to make a total score. Total scores range from 0 to 40, which higher scores indicating more severe gambling symptoms (worse outcome).Administered every week for the first 8 weeks and every other week for the remaining 10 weeks. Final visit scores were the scores measured at the last visit for each participant; data from previous visits were not combined to compute this value.
次要结局
未报告次要终点