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NCT04468776 · ClinicalTrials.gov registry record · Phase 4
CBT-I or Zolpidem/Trazodone for Insomnia
A Phase 4 study, sponsored by California Pacific Medical Center Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 155
- Enrollment target
NCT04468776 is a Phase 4 study that has completed, run by California Pacific Medical Center Research Institute. The registered enrollment target is 155 participants.
The verdict
NCT04468776, a Phase 4 study, has completed, sponsored by California Pacific Medical Center Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 155 participants
- Enrollment target
Study Summary
This study is a randomized (1:1:1) comparative effectiveness trial of medication (zolpidem or trazodone), cognitive-behavioral therapy for insomnia (CBT-I), and the combination (medication + CBT-I) for the treatment of chronic insomnia in men and women aged 18-80 living in rural areas with 1 year of follow-up. A total of 155 participants will be enrolled and randomized in the United States. This trial is funded by the Patient-Centered Outcomes Research Institute.
Interventions
- DRUG Trazodone
- DRUG Zolpidem
- BEHAVIORAL Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2022-02-25 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04468776
The ClinicalTrials.gov registry entry for NCT04468776 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is California Pacific Medical Center Research Institute, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trazodone is the first listed.
NCT04468776 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04468776 about?
NCT04468776 is a clinical study titled "CBT-I or Zolpidem/Trazodone for Insomnia". This study is a randomized (1:1:1) comparative effectiveness trial of medication (zolpidem or trazodone), cognitive-behavioral therapy for insomnia (CBT-I), and the combination (medication + CBT-I) for the treatment of chronic insomnia in men and women aged 18-80 living in rural areas with 1 year of...
What is the current status of trial NCT04468776?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 155 participants. The study started on 2022-02-25. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT04468776?
The interventions under investigation include: Trazodone (DRUG), Zolpidem (DRUG), Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04468776?
This trial is sponsored by California Pacific Medical Center Research Institute, which has 29 total clinical trials registered on ClinicalTrials.gov.
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