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ACTIVE NOT RECRUITING Phase 3

Use of Blinded Tapering for Hypnotic Discontinuation

NCT04050176 · View on ClinicalTrials.gov ↗

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.

Interventions

  • BEHAVIORAL Hypnotic Medication Open-Label Taper
  • BEHAVIORAL Hypnotic Medication Blinded Taper

Study Locations (1)

Colorado

  • National Jewish Health — Denver

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2019-12-16
Est. Completion 2026-06-30
Phase Phase 3

Sponsor

National Jewish Health

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04050176

The ClinicalTrials.gov registry entry for NCT04050176 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Jewish Health, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04050176 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04050176?

The interventions under investigation include: Hypnotic Medication Open-Label Taper (BEHAVIORAL), Hypnotic Medication Blinded Taper (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04050176?

This trial is sponsored by National Jewish Health, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial