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NCT03511209 · ClinicalTrials.gov registry record · NA
Discontinuation of Hypnotics in Older Veterans
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 132
- Enrollment target
NCT03511209: Completed NA study, sponsored by VA Office of Research and Development.
NCT03511209 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 132 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03511209, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
Study Summary
Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use among older adults. Currently, there are two main treatments to help patients stop using hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic is ultimately discontinued. For safety, the process of decreasing the daily dose is usually supervised by a physician. The second is a treatment for insomnia called cognitive behavioral therapy for insomnia (CBTI). This study will compare a novel hypnotic tapering method to the usual tapering method offered to older Veterans. The purpose of the study is to determine if the novel tapering method is more effective than the usual tapering method, both in terms of hypnotic discontinuation and improvement in insomnia severity. Participants will be recruited from among Veterans 55 years and older who receive care from one VA Healthcare System. Following a baseline assessment, participants will be randomly assigned to one of the two 8-week treatment groups (66 participants per group). Each treatment group will receive CBTI, however, one group will receive the novel tapering program and the other group the usual tapering program. Follow-up assessments will be conducted at post-treatment and at 6-months after completion of the treatment. If the novel tapering program is effective, it will represent a treatment option that can be offered to older Veterans who want to discontinue hypnotics. This tapering program could help VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce the risk of falls and hip fractures, whic
Primary Outcome
The percentage of participants who had stopped taking a benzodiazepine or z-drug at follow-up. This outcome was measured with 7-day self-reported medication logs.
Interventions
- BEHAVIORAL CBTI plus taper method A
- BEHAVIORAL CBTI plus taper method B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2018-12-10 |
| Est. Completion | 2023-11-27 |
| Phase | NA |
What the finished NCT03511209 record still lists
NCT03511209 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which CBTI plus taper method A is the first listed.
NCT03511209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03511209 about?
NCT03511209 is a clinical study titled "Discontinuation of Hypnotics in Older Veterans". Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. The De...
What is the current status of trial NCT03511209?
This trial is currently completed. It is a NA study. The enrollment target is 132 participants. The study started on 2018-12-10. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT03511209?
The interventions under investigation include: CBTI plus taper method A (BEHAVIORAL), CBTI plus taper method B (BEHAVIORAL).
Who is sponsoring clinical trial NCT03511209?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03511209's enrollment target sits among peer trials
132 729th of 2000 higher than 1,269 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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