Naltrexone Treatment in Pathologic Gambling Disorder

纳曲酮治疗病理性赌博障碍

• 批准号: 6738125
• 负责人: SUCK W KIM
• 金额: $ 15.47万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-15 至 2005-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6738125
• 关键词: analgesics; behavior test; clinical research; dosage; drug screening /evaluation; gamblings; gender difference; human subject; human therapy evaluation; impulsive behavior; interview; mental disorder chemotherapy; naltrexone; patient oriented research; psychometrics; questionnaires; sign /symptom; transaminases

DESCRIPTION (provided by applicant): This R21 application proposes a novel use of naltrexone as treatment for Pathological Gambling Disorder (PGD) patients with severe urge symptoms. Although PGD is a prominent and growing social problem, there is no established drug treatment for this disorder. Our preliminary investigations demonstrate statistically significant findings that an opioid antagonist, may serve as a viable treatment option for PGD patients with severe urges. In 1994, naltrexone was approved to treat alcoholism (at a dose limited to 50 mg/day, but the use of naltrexone has since languished. In an effort to further pursue the use of naltrexone, we adopted a novel alternative approach. First, we focused our efforts only on a subset of PGD patients who had severe urge symptoms, as opposed to the entire PGD population. Second, we tested naltrexone at doses higher than 50 mg/day (up to 250 mg/day). Third, we addressed the side effect of hepatic transaminase revelation, an established adverse effect of naltrexone at doses above 50 mg/day, and we found a solution, such that dosages up to 250 mg/day were well tolerated and safe during an 11-week time period of use. In our three preliminary investigations, we found statistically significant results in our case study, open study, and double blind study, showing that naltrexone doses above 50 mg/day are effective in treating PGD patients with severe urges. We present the design of our proposed double-blind study, placebo-controlled, dose-finding study, which will expand upon our preliminary work and will establish the optimal dose for efficacy, whether efficacy is maintained for 16 weeks, and whether efficacy is disrupted in a male: female ratio analogous to that of the PGD population in the U.S. The implications of our study expand from PGD to other impulse control disorders, including compulsive shopping, kleptomania and possible alcoholism.

描述(由申请人提供)：这份R21申请提出了一种新的纳曲酮用于治疗具有严重冲动症状的病理性赌博障碍(PGD)患者。尽管PGD是一个突出且日益严重的社会问题，但目前还没有针对这种疾病的既定药物治疗。我们的初步调查显示，有统计学意义的发现表明，阿片类拮抗剂可能是有严重冲动的PGD患者的可行治疗选择。1994年，纳曲酮被批准用于治疗酒精中毒(剂量限制为每天50毫克)，但此后纳曲酮的使用一直停滞不前。为了进一步探索纳曲酮的用途，我们采用了一种新的替代方法。 首先，我们只将我们的努力集中在有严重冲动症状的PGD患者子集上，而不是整个PGD人群。其次，我们测试了纳曲酮的剂量高于50毫克/天(最高为250毫克/天)。第三，我们解决了肝脏转氨酶暴露的副作用，即纳曲酮在每天50毫克以上剂量的公认不良反应，我们找到了一种解决方案，在11周的使用期间，每天250毫克的剂量是很好的耐受性和安全性。在我们的三项初步调查中，我们在病例研究、开放研究和双盲研究中发现了统计学上的显著结果，表明纳曲酮剂量超过50毫克/天对伴有严重冲动的PGD患者有效。 我们提出了我们拟议的双盲研究的设计，安慰剂对照，剂量发现研究，它将在我们前期工作的基础上扩展，并将建立疗效的最佳剂量，有效性是否保持16周，以及有效性是否在类似于美国PGD人群的男性：女性比例中被破坏。我们的研究的影响从PGD扩展到其他冲动控制障碍，包括强迫购物，盗窃症和可能的酒精中毒。