drugset / Trial / NCT04468776
CBT-I or Zolpidem/Trazodone for Insomnia
Phase 4
Completed
155 enrolled
California Pacific Medical Center Research Institute
Patient-Centered Outcomes Research Institute · collabUniversity of Arizona · collabUniversity of Illinois at Chicago · collabUniversity of Pittsburgh · collabUniversity of Virginia · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2022-02-25
- Primary completion
- 2024-06-30
- Completion
- 2024-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trazodone | Small molecule | — | — |
| Subject | Zolpidem | Small molecule | — | — |