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NCT06435520 · ClinicalTrials.gov registry record · Phase 4
Enhancing Hypnotic Medication Discontinuation in Primary Care
A Phase 4 study of Insomnia and Hypnotic Dependence, sponsored by National Jewish Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 430
- Enrollment target
- 1
- Study location
NCT06435520 is a Phase 4 study of Insomnia and Hypnotic Dependence that is actively recruiting participants, run by National Jewish Health. The registered enrollment target is 430 participants, above the 167-participant average among 151 other Insomnia trials with a reported enrollment target (157% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06435520, a Phase 4 study of Insomnia and Hypnotic Dependence, is actively recruiting participants, sponsored by National Jewish Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 430 participants
- Enrollment target
- 1
- Study location
Study Summary
Many individuals with insomnia seek treatment in primary care settings, where they often receive prescription hypnotic medications as their first and sometimes only treatment. However, extended use of these medications can lead to reliance and increased health risks, such as falls and cognitive impairments. While evidence-based approaches like physician-supervised medication tapering exist, they're not widely available in primary care. Most primary care providers are willing to explore non-drug treatments like cognitive behavioral therapy for insomnia (CBTI), but accessing such treatments can be challenging outside of specialized sleep centers. This gap between research and practice underscores the need for cost-effective interventions to manage insomnia and help patients reduce their reliance on hypnotics in primary care. In response to this need, the project aims to conduct a large randomized trial comparing a combined digital CBT (dCBTI) and medication tapering intervention with medication tapering alone. We'll recruit 430 patients reliant on hypnotics from 8-10 primary care clinics affiliated with the University of Colorado Medical School. The main goal is to assess the effectiveness of dCBTI+SMT compared to SMT alone in reducing hypnotic use and improving insomnia symptoms. Additionally, we'll evaluate factors affecting the adoption and implementation of these interventions at the patient, provider, and system levels. This information will inform future implementation strategies to disseminate effective treatments in primary care. Furthermore, we'll gather data to identify which patients benefit most from dCBTI+SMT. Overall, this study will provide valuable insights into the feasibility, clinical utility, and acceptability of these interventions in managing insomnia and reducing reliance on hypnotic medications in primary care. Ultimately, this project represents a crucial first step toward making accessible and cost-effective strategies available to improv
Conditions Studied
Interventions
- BEHAVIORAL Digital Cognitive Behavioral Therapy
- BEHAVIORAL Structured Medication Tapering
Study Locations (1)
Colorado
- National Jewish Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06435520
The ClinicalTrials.gov registry entry for NCT06435520 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 430 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 167-participant average among 151 other Insomnia trials with a reported enrollment target (157% higher). The listed sponsor is National Jewish Health, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Digital Cognitive Behavioral Therapy is the first listed.
NCT06435520 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT06435520 about?
NCT06435520 is a clinical study titled "Enhancing Hypnotic Medication Discontinuation in Primary Care". Many individuals with insomnia seek treatment in primary care settings, where they often receive prescription hypnotic medications as their first and sometimes only treatment. However, extended use of these medications can lead to reliance and increased health risks, such as falls and cognitive impa...
What is the current status of trial NCT06435520?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 430 participants. The study started on 2025-01-01. Estimated completion is 2029-06-30.
What conditions does trial NCT06435520 study?
This clinical trial studies the following conditions: Insomnia, Hypnotic Dependence.
What interventions are being tested in trial NCT06435520?
The interventions under investigation include: Digital Cognitive Behavioral Therapy (BEHAVIORAL), Structured Medication Tapering (BEHAVIORAL).
Who is sponsoring clinical trial NCT06435520?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06435520 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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