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NCT00662155 · ClinicalTrials.gov registry record · NA
The Role of Partial Reinforcement in the Long Term Management of Insomnia
A NA study of Primary Insomnia, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 129
- Enrollment target
- 1
- Study location
NCT00662155 is a NA study of Primary Insomnia that has completed, run by University of Pennsylvania. The registered enrollment target is 129 participants, above the 115-participant average among 12 other Primary Insomnia trials with a reported enrollment target (12% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00662155, a NA study of Primary Insomnia, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
- 1
- Study location
Study Summary
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 cap
Conditions Studied
Interventions
- DRUG Placebos
- DRUG Zolpidem
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2006-07 |
| Est. Completion | 2013-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00662155
The ClinicalTrials.gov registry entry for NCT00662155 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 12 other Primary Insomnia trials with a reported enrollment target (12% higher). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebos is the first listed.
NCT00662155 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00662155 about?
NCT00662155 is a clinical study titled "The Role of Partial Reinforcement in the Long Term Management of Insomnia". 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 e...
What is the current status of trial NCT00662155?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2006-07. Estimated completion is 2013-06.
What conditions does trial NCT00662155 study?
This clinical trial studies the following conditions: Primary Insomnia.
What interventions are being tested in trial NCT00662155?
The interventions under investigation include: Placebos (DRUG), Zolpidem (DRUG).
Who is sponsoring clinical trial NCT00662155?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00662155 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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