Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by California Pacific Medical Center Research Institute.
NCT04468776 is a Phase 4 study that has completed, run by California Pacific Medical Center Research Institute. The registered enrollment target is 155 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in Insomnia Severity Index score from baseline to follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Baseline ISI, Treatment Arm, Visit and Treatment Arm\*Vis
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 |
What the finished NCT04468776 record still lists
NCT04468776 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Trazodone is the first listed.
NCT04468776 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04468776's enrollment target sits among peer trials
155 525th of 2000 higher than 1,473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03223610 · 155 participants · Phase 1
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
- NCT05072483 · 155 participants
Natural History Study of CADASIL
- NCT05086497 · 155 participants · NA
WBSI Guided Personalized Delivery of TTFields
- NCT05412069 · 155 participants · NA
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI