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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: Recruiting Phase 4 study of Insomnia and Hypnotic Dependence, sponsored by National Jewish Health.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Rates of successful hypnotic discontinuation among participants

Interventions

  • BEHAVIORAL Digital Cognitive Behavioral Therapy
  • BEHAVIORAL Structured Medication Tapering

Study Locations (1)

Colorado

  • National Jewish Health - Denver

Trial Details

FieldValue
Enrollment Target 430 participants
Start Date 2025-01-01
Est. Completion 2029-06-30
Phase Phase 4
National Jewish Health

83 total trials

What NCT06435520 shows while recruiting

NCT06435520 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, above the 167-participant average among 151 other Insomnia trials with a reported enrollment target (157% higher).

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 a single indexed study location in 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.

Similar trials for Insomnia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06435520's enrollment target sits among peer trials

430 14th of 151 higher than 138 of 151 other Insomnia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Insomnia 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

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Source: ClinicalTrials.gov NCT06435520, the US trial registry maintained by the National Library of Medicine. NCT06435520 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.