Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Gambling craving
研究概览
简要总结
Objectives: Pathological gambling (PG) is a prevalent disorder with no approved pharmacological treatment. Previous reports suggest that topiramate could be useful in reducing impulsivity in PG, and craving in other addictions. The goal of this study was to investigate the effectiveness of topiramate combined with brief cognitive restructuring in treating PG. Methods: 38 PG patients were randomized to either topiramate (N=18) or placebo (N=20) in a 12-week double-blind trial; all patients received brief cognitive restructuring. The main outcome measures were craving, gambling behaviour, gambling cognitive distortions, impulsivity, depression and social adjustment.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current Diagnostic and Statistical Manual Fourth Edition Text Revised (DSM-IV-TR) diagnosis of pathological gambling
- •a betting frequency of at least once a week in the last 30 days
- •women within fertility age had to be already practicing an acceptable contraception method and to be negative at a pregnancy test.
排除标准
- •illiteracy
- •breastfeeding for women
- •previous history of alcohol abuse/dependence with current elevation of liver enzymes, or a present diagnosis of alcohol abuse/dependence
- •past or current drug abuse/dependence, except for nicotine dependence
- •history of current or past DSM-IV-TR diagnosis of bipolar disorder, schizophrenia, psychosis or any neuropsychiatric condition causing cognitive impairment
- •a history of suicide attempt or acute suicide risk
- •severe depression indicated by a score equal to or higher than 30 at the Beck Depression Inventory
- •current participation in psychotherapy for pathological gambling, including Gamblers Anonymous in the past 3 months
- •current use of mood stabilizers, antidepressants, antipsychotics, except occasional use of benzodiazepines
- •cardiovascular disease including a history of heart attack, stroke, arrhythmia, cardiac failure in the past 5 years
- •chronic or acute renal and liver failure
- •a personal or family history of nephrolithiasis
- •immunodeficiency
- •any blood dyscrasia.
研究组 & 干预措施
Topiramate
A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention.
干预措施: Topiramate flexible dosage (Drug)
Topiramate
A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention.
干预措施: 4-session gambling cognitive restructuring (Behavioral)
Placebo
A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention.
干预措施: Placebo matching tablets (Drug)
Placebo
A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention.
干预措施: 4-session gambling cognitive restructuring (Behavioral)
结局指标
主要结局
Gambling craving
时间窗: 12 weeks
The scale selected for this purpose was The Gambling Symptom Assessment Scale (G-SAS), it is a one-dimension self-report scale which assesses mostly gambling craving, related thoughts and behaviors. Reference: Kim SW, Grant JE, Potenza MN, Blanco C, Hollander E. The Gambling Symptom Assessment Scale (G-SAS): a reliability and validity study. Psychiatry Res. 2009 Mar 31;166(1):76-84.
次要结局
- Gambling behavior(12 weeks)
研究者
Hermano Tavares
Associate Professor
University of Sao Paulo