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NCT02831894 · ClinicalTrials.gov registry record · Phase 2
The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation
A Phase 2 study, sponsored by National Jewish Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT02831894 is a Phase 2 study that has completed, run by National Jewish Health. The registered enrollment target is 74 participants.
The verdict
NCT02831894, a Phase 2 study, has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study Summary
Treatment seeking insomnia sufferers most often present in primary care venues where the first and usually only treatment is a prescription for a sedative hypnotic, typically a benzodiazepine or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia relief. However, more than 65 percent of individuals who are prescribed hypnotics use them for more than a year, and over 30 percent remain on these agents for more than five years. Whereas some patients may appreciate partial or full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of these agents may not represent optimal therapy. Many insomnia patients who participate in non drug insomnia therapy such as as cognitive behavioral insomnia therapy or Cognitive Behavioral Therapy For Insomnia (CBTI) achieve sustained insomnia remission lon after a time limited course of treatment. However it is difficult for most long term hypnotic users to convert to a self management approach. Intervention that combine CBTI with a supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50 percent of patients who receive this treatment either fail to discontinue hypnotics or resume them over time. Previous research provides only rudimentary understanding of how to help long term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBTI techniques. This R34 gathered key pilot data to address these limitations. Specifically this project compared the currently recommended tapering pace which is a 25 percent dose reduction every two weeks with a slower 10 percent dose reduction every two weeks. The study also conducted all tapering in double blinded fashion. A total of 78 patients were enrolled and first completed a course of CBTI over a six week period. They they were randomized to of of the two tapering conditions or to a control (CTRL) condition in which thei
Interventions
- DRUG 0% Hypnotic Medication Taper
- DRUG 25% Hypnotic Medication Taper
- DRUG 10% Hypnotic Medication Taper
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2015-11-02 |
| Est. Completion | 2019-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02831894
The ClinicalTrials.gov registry entry for NCT02831894 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Jewish Health, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 0% Hypnotic Medication Taper is the first listed.
NCT02831894 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02831894 about?
NCT02831894 is a clinical study titled "The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation". Treatment seeking insomnia sufferers most often present in primary care venues where the first and usually only treatment is a prescription for a sedative hypnotic, typically a benzodiazepine or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfa...
What is the current status of trial NCT02831894?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2015-11-02. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT02831894?
The interventions under investigation include: 0% Hypnotic Medication Taper (DRUG), 25% Hypnotic Medication Taper (DRUG), 10% Hypnotic Medication Taper (DRUG).
Who is sponsoring clinical trial NCT02831894?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
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