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

描述（由申请人提供）：缺乏对安慰剂效应作为一种现象本身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。拟议的调查1）是试图推进从描述性的安慰剂效应的实验分析，考虑到经典的条件作用，和2）检查部分强化的临床意义，因为它适用于治疗失眠。原发性失眠受试者将接受唑吡坦治疗1个月，然后随机分配至4组之一，治疗12周：1例患者每晚接受全剂量唑吡坦（持续强化），1例患者在28个夜晚中的14个夜晚接受全剂量唑吡坦，其中安慰剂在非药物夜晚提供一个在28个夜晚中的14个晚上接受全剂量唑吡坦，其中在非药物夜晚不吸入药丸（间歇给药），一个在每晚基础上接受5 mg剂量唑吡坦（用标准剂量的一半连续加强）。治疗后，受试者将进入消退方案，在此期间，他们将1）继续实验期间分配的时间表，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，将通过睡眠日记每天监测睡眠和日常功能。假设保持累积剂量恒定，与接受标准剂量一半或使用频率一半的连续强化的受试者相比，部分强化方案将使患者能够更好地维持其临床获益。相关性：拟议的研究不是试图提供一种替代药物治疗的行为，而是试图在药物治疗方案的设计中承认和利用行为维度。拟议研究的价值在于它能够以增加药物治疗的持久性的方式提供失眠的长期治疗，同时减少所需药物的总量。如果在当前的应用中证明有效，这种药物治疗和安慰剂效应的新方法可能会刺激用于治疗各种慢性疾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.