Naltrexone Treatment in Pathologic Gambling Disorder

纳曲酮治疗病理性赌博障碍

• 批准号: 6647697
• 负责人: SUCK W KIM
• 金额: $ 15.48万
• 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 2005-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6647697
• 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）：该R21申请提出了纳洛酮作为治疗具有严重冲动症状的病理性赌博障碍（PGD）患者的新用途。虽然PGD是一个突出的和日益增长的社会问题，有没有既定的药物治疗这种疾病。我们的初步研究表明，阿片类药物拮抗剂，可能作为一个可行的治疗选择PGD患者严重的冲动，统计学上显着的结果。1994年，纳洛酮被批准用于治疗酒精中毒（剂量限制在50 mg/天，但纳洛酮的使用从此消失。为了进一步追求纳洛酮的使用，我们采用了一种新的替代方法。 首先，我们只将精力集中在有严重急迫症状的PGD患者的一个子集上，而不是整个PGD人群。其次，我们测试了纳洛酮的剂量高于50 mg/天（高达250 mg/天）。第三，我们解决了肝转氨酶暴露的副作用，这是纳洛酮在剂量高于50 mg/天时的既定不良反应，我们找到了一种解决方案，使得剂量高达250 mg/天在11周的使用期间耐受性良好且安全。在我们的三项初步研究中，我们在我们的病例研究、开放研究和双盲研究中发现了统计学显著的结果，表明纳洛酮剂量超过50 mg/天对治疗PGD患者的严重冲动是有效的。 我们提出了我们提出的双盲研究、安慰剂对照、剂量探索研究的设计，该研究将扩展我们的初步工作，并将确定疗效的最佳剂量，疗效是否维持16周，以及男性疗效是否被破坏：女性比例类似于美国PGD人群的比例。我们研究的意义从PGD扩展到其他冲动控制障碍，包括强迫性购物盗窃癖和可能的酗酒