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NCT03774810 · ClinicalTrials.gov registry record · Phase 4
Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia
A Phase 4 study of Insomnia and Insomnia Chronic, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 197
- Enrollment target
- 1
- Study location
NCT03774810 is a Phase 4 study of Insomnia and Insomnia Chronic that has completed, run by University of Pennsylvania. The registered enrollment target is 197 participants, above the 169-participant average among 151 other Insomnia trials with a reported enrollment target (17% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03774810, a Phase 4 study of Insomnia and Insomnia Chronic, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 197 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is a three phase sequential study of the medical treatment of insomnia with zolpidem. All participating subjects will receive one month of standard nightly treatment. If the subject has a positive treatment response they continue in the study and are randomized to one of four conditions: intermittent dosing (3-5 pills week, full dose), or one of three variable dose conditions (nightly pill use where any given pill is a variable dose). Standard treatment will last for 4 weeks. The experimental phase will extend over two periods. The first period will last for 12 weeks. The second period will last for 36 weeks. Both periods include: • Taking a pill 30 minutes prior to bedtime. In one case, this will involve taking 3-5 pills per week. In the remaining condition pills will be taken on each and every night. Depending on the specific group that the subject is assigned to, they will either receive 10mg or 5mg of zolpidem (variable by age and sex) or a variable dose of zolpidem on a nightly basis (range from 0 mg to 10 mg per night). * Completing a sleep diary each day; * Completing 6 to 7 questionnaires each week; * A monthly visit to Penn to return your medication foil packs and to receive a new foil pack with the next month of medication. During Phases 3\&4, the subject will be asked to undergo quarter annual physicals so that we can optimally track their health and wellbeing. The physicals will involve standard vitals measures (e.g., temperature, blood pressure, height and weight, etc.) and, based on the judgement of the research clinician, may involve an EKG and blood and urine chemistries. If the subject does not experience a treatment response or (following a treatment response) experiences a relapse of insomnia, they will not continue in the study but will be given the opportunity to be treated with Cognitive Behavioral Therapy for Insomnia (CBT-I) at no cost. Assessments of the subjects clinical status will be based on your daily sleep diaries and we
Conditions Studied
Interventions
- DRUG Zolpidem tartrate
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03774810
The ClinicalTrials.gov registry entry for NCT03774810 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 197 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 169-participant average among 151 other Insomnia trials with a reported enrollment target (17% higher). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which Zolpidem tartrate is the first listed.
NCT03774810 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03774810 about?
NCT03774810 is a clinical study titled "Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia". The study is a three phase sequential study of the medical treatment of insomnia with zolpidem. All participating subjects will receive one month of standard nightly treatment. If the subject has a positive treatment response they continue in the study and are randomized to one of four conditions: i...
What is the current status of trial NCT03774810?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 197 participants. The study started on 2019-04-15. Estimated completion is 2024-09-30.
What conditions does trial NCT03774810 study?
This clinical trial studies the following conditions: Insomnia, Insomnia Chronic.
What interventions are being tested in trial NCT03774810?
The interventions under investigation include: Zolpidem tartrate (DRUG).
Who is sponsoring clinical trial NCT03774810?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03774810 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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Related
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