Treatment of Addiction to Nicotine in Schizophrenia

精神分裂症尼古丁成瘾的治疗

• 批准号: 6947909
• 负责人: DOUGLAS MICHAEL ZIEDONIS
• 金额: $ 2.75万
• 依托单位: UNIV OF MED/DENT NJ-R W JOHNSON MED SCH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-05 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6947909
• 关键词: behavioral /social science research tag; clinical research; drug abuse chemotherapy; drug addiction; human subject; method development; nicotine; nicotine replacement; patient oriented research; questionnaires; schizophrenia; smoking; tobacco abuse; transdermal drug delivery

DESCRIPTION (provided by applicant): Over 75% of patients with schizophrenia are nicotine dependent, and most of them die of smoking related illnesses. Few are offered nicotine dependence treatment in primary care or mental health settings. Unfortunately there have been few clinical treatment studies, and there continues to be a great need to develop, test, and disseminate behavioral therapy and medication management approaches for nicotine dependence treatment in mental health settings. Treatment manuals, training programs, and clinical studies are needed. Such therapies should reflect the unique needs of this population, and be "real world applicable." This grant reapplication responds to the concerns and helpful suggestions of the initial Review Committee and proposes to further develop and pilot test our behavioral therapy approach of Treating Addiction to Nicotine in Schizophrenia (TANS). In response to the Review Committee, this reapplication clarifies and better links TANS to its the empirical foundation, addresses "real world applicability," changes the control treatment, and modifies the assessment battery. We propose to develop and test Stage 1 Therapy Development Products (therapy manual, adherence scales, and training program) of TANS and our new control treatment of Nicotine Dependence Medication Management by Mental Health Providers (Medication Management). We agree with the Review Committee's suggestion to compare TANS to a lower intensity control treatment in regards to (1) engagement, retention, and extended abstinence during the initial three months, (2) relapse prevention during months four through six, and (3) longer-term abstinence at later follow-ups. After an initial open trial of 20 subjects to develop the therapy products, we propose to do a larger study of 100 subjects randomized to TANS versus Medication Management. The proposed study is important because it will create two real world applicable psychosocial treatments that could help clinicians in the mental health system better address tobacco and researchers doing medication or Stage II therapy studies. The study will assess whether medication management is sufficient in this population, and whether lengthening treatment will improve long-term outcomes.

描述（由申请人提供）： 超过75%的精神分裂症患者依赖尼古丁，其中大多数死于与吸烟有关的疾病。在初级保健或心理健康环境中，很少有人提供尼古丁依赖治疗。不幸的是，临床治疗研究很少，并且仍然非常需要开发，测试和传播心理健康环境中尼古丁依赖治疗的行为疗法和药物管理方法。需要治疗手册、培训计划和临床研究。这种疗法应该反映这一人群的独特需求，并且是“真实的世界适用的”。“这项拨款的重新申请回应了最初审查委员会的关注和有益的建议，并建议进一步发展和试点测试我们的行为治疗方法，治疗精神分裂症尼古丁成瘾（TANS）。作为对审查委员会的回应，此次重新申请澄清并更好地将TANS与其经验基础联系起来，解决了“真实的世界适用性”问题，改变了对照处理，并修改了评估组合。我们建议开发和测试TANS的第一阶段治疗开发产品（治疗手册，依从性量表和培训计划）以及我们的新对照治疗尼古丁依赖药物管理由精神卫生提供者（药物管理）。我们同意审查委员会的建议，将TANS与较低强度的控制治疗进行比较，包括（1）最初三个月的参与，保留和延长禁欲，（2）第四至第六个月的复发预防，以及（3）后期随访的长期禁欲。在对20名受试者进行初步开放试验以开发治疗产品后，我们建议进行一项更大规模的研究，将100名受试者随机分配到TANS与药物管理组。这项拟议中的研究很重要，因为它将创造两个真实的世界适用的心理社会治疗，可以帮助精神卫生系统的临床医生更好地解决烟草和研究人员进行药物或第二阶段治疗研究。该研究将评估药物管理在这一人群中是否足够，以及延长治疗是否会改善长期结局。