The Role of Partial Reinforcement in the Long Term Management of Insomnia

描述(由申请人提供)：缺乏对安慰剂效应本身作为一种现象的科学关注，可能反映了缺乏组织现有数据和设计新研究的理论立场。拟议的研究1)试图从安慰剂效应的描述性分析发展到实验分析，考虑到经典的条件反射效应，2)检查部分强化应用于失眠治疗的临床意义。原发性失眠症患者将接受为期一个月的唑吡坦治疗，然后被随机分成四组，为期12周：一组在夜间接受全剂量唑吡坦(持续强化)，一组在28晚中的14晚接受全剂量唑吡坦治疗，其中在非药物夜晚提供安慰剂(部分强化)，一组在28晚中的14晚接受全剂量唑吡坦治疗，在非药物之夜不吸食药片(间歇给药)，以及一组在夜间接受5毫克剂量的唑吡坦(持续强化，标准剂量的一半)。治疗后，受试者将进入消退方案，在此期间，他们将1)继续按照实验期间分配的时间表进行，2)仅接受安慰剂，或3)既不接受药物也不接受安慰剂。在研究期间，睡眠和日常功能将通过睡眠日记进行每日监测。它假设，在保持累积剂量不变的情况下，与接受标准剂量一半或使用频率一半的持续强化的受试者相比，部分强化时间表将使患者能够更好地保持他们的临床成果。相关性：拟议的研究并不是试图提供药物治疗的行为替代方案；它是试图承认并利用药物治疗方案设计中的行为维度。拟议研究的价值在于它有能力为失眠提供长期治疗，以增加药物治疗的持久性，同时减少所需的总用药量。如果在目前的应用中被证明是有效的，这种药物治疗和安慰剂效应的新方法可能会刺激治疗各种慢性病的新的跨学科研究。

DESCRIPTION (provided by applicant): The lack of scientific attention devoted to the placebo effect as a phenomenon in its own right probably reflects the paucity of theoretical positions within which to organize the existing data and design new research. The proposed investigation 1) is an attempt to advance from a descriptive to an experimental analysis of the placebo effect, taking into account classical conditioning effects, and 2) examines the clinical implications of partial reinforcement as it is applied to the treatment of insomnia. Subjects with primary insomnia will be treated with zolpidem for a period of one month and then randomized to one of four groups for a period of 12 weeks: one receiving full dose zolpidem on a nightly basis (continuous reinforcement), one receiving full dose zolpidem on 14 of 28 nights where placebo is provided on non-drug nights (partial reinforcement), one receiving full dose zolpidem on 14 of 28 nights where no pills are imbibed on non-drug nights (intermittent dosing), and one receiving 5 mg dose zolpidem on a nightly basis (continuous reinforcement with half the standard dose). Following treatment, subjects will be entered into an extinction protocol during which they will 1) continue on the schedule assigned during the experimental period, 2) receive only placebo, or 3) receive neither drug nor placebo. Sleep and daily functioning will be monitored on a daily basis via sleep diaries for the duration of the study. It is hypothesized that, holding cumulative dose constant, a partial schedule of reinforcement will enable patients to better maintain their clinical gains as compared to subjects that receive either continuous reinforcement with half the standard dose or half the frequency of use. Relevance: The proposed research is not an attempt to offer a behavioral alternative to drug treatment; it is an attempt to acknowledge and capitalize on a behavioral dimension in the design of drug treatment protocols. The value of the proposed research resides in its capacity to provide for the long term treatment of insomnia in a manner that increases the durability of pharmacotherapy while reducing the overall amount of medication required. If proven effective in the current application, this new approach to pharmacotherapy and placebo effects is likely to stimulate new interdisciplinary research for the treatment of a variety of chronic diseases.