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NCT04050176 · ClinicalTrials.gov registry record · Phase 3
Use of Blinded Tapering for Hypnotic Discontinuation
A Phase 3 study of Hypnotic Dependence Among Those With Insomnia, sponsored by National Jewish Health.
- Active
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
- 1
- Study location
NCT04050176: Active Phase 3 study of Hypnotic Dependence Among Those With Insomnia, sponsored by National Jewish Health.
NCT04050176 is a Phase 3 study of Hypnotic Dependence Among Those With Insomnia that is active but no longer recruiting, run by National Jewish Health. The registered enrollment target is 260 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04050176, a Phase 3 study of Hypnotic Dependence Among Those With Insomnia, is active but no longer recruiting, sponsored by National Jewish Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will employ a randomized longitudinal clinical trial design to evaluate the relative efficacy of a blinded hypnotic tapering protocol when used in combination with therapist delivered Cognitive Behavioral Therapy for Insomnia (CBTI) for enhancing hypnotic discontinuation rates. A blinded SMT+CBTI intervention will be compared to open-label SMT+CBTI.
Primary Outcome
the proportion of participants in each treatment group who achieve full withdrawal of their BZD/BzRA medication without switching to any alternative prescription medication, used on- (e.g., suvorexant) or off-label (e.g. trazodone) to promote sleep
Conditions Studied
Interventions
- BEHAVIORAL Hypnotic Medication Open-Label Taper
- BEHAVIORAL Hypnotic Medication Blinded Taper
Study Locations (1)
Colorado
- National Jewish Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT04050176 still lists
NCT04050176 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Hypnotic Dependence Among Those With Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Hypnotic Medication Open-Label Taper is the first listed.
NCT04050176 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04050176 about?
NCT04050176 is a clinical study titled "Use of Blinded Tapering for Hypnotic Discontinuation". The study will employ a randomized longitudinal clinical trial design to evaluate the relative efficacy of a blinded hypnotic tapering protocol when used in combination with therapist delivered Cognitive Behavioral Therapy for Insomnia (CBTI) for enhancing hypnotic discontinuation rates. A blinded S...
What is the current status of trial NCT04050176?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2019-12-16. Estimated completion is 2026-06-30.
What conditions does trial NCT04050176 study?
This clinical trial studies the following conditions: Hypnotic Dependence Among Those With Insomnia.
What interventions are being tested in trial NCT04050176?
The interventions under investigation include: Hypnotic Medication Open-Label Taper (BEHAVIORAL), Hypnotic Medication Blinded Taper (BEHAVIORAL).
Who is sponsoring clinical trial NCT04050176?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04050176 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04050176's enrollment target sits among peer trials
260 1231st of 2000 higher than 767 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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