Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Rochester National Institutes of Health (NIH) |
---|---|
Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00662155 |
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.
Condition | Intervention |
---|---|
Primary Insomnia |
Drug: Zolpidem |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Efficacy Study |
Official Title: | The Role of Partial Reinforcement in the Long Term Manangement of Insomnia |
Ages Eligible for Study: | 25 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with insomnia will meet RDC criteria for psychophysiologic insomnia(99). These criteria are provided in Appendix 2. In addition, the complaint of disturbed sleep will have one or more of the following characteristics:
Additionally, total sleep time will not exceed 6 hours (unless the sleep efficiency quotient is < 80%) and the problem frequency must be greater than 4 nights/ week (severe insomnia) with a problem duration > 6 months (chronic insomnia). This profile must be evident at both intake (based on retrospective reports) and as an average profile from the two weeks of baseline diaries (based on prospective sampling).
Exclusion Criteria:
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Robert Ader, Ph.D. | University of Rochester |
Responsible Party: | University of Rochester ( Robert Ader, Ph.D. / Primay Investigator ) |
Study ID Numbers: | RSRB # 14533, 1 R01 AT003332-01A1 |
Study First Received: | April 16, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00662155 History of Changes |
Health Authority: | United States: Institutional Review Board |
Primary Insomnia Cognitive Behavioral Therapy Insomnia Sleep |
Zolpidem Ambien CBT CBT-I |
Zolpidem Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Mental Disorders GABA Agonists |
Hypnotics and Sedatives Central Nervous System Depressants Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Zolpidem Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Central Nervous System Depressants Dyssomnias Sleep Disorders |
Pharmacologic Actions Sleep Disorders, Intrinsic Mental Disorders Therapeutic Uses GABA Agonists Hypnotics and Sedatives GABA Agents Central Nervous System Agents |