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NCT04581603 · ClinicalTrials.gov registry record · Phase 4
CBT-I Augmentation of Medication for Drinking in AUD
A Phase 4 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
NCT04581603: Clinical Trial Phase 4 study, sponsored by VA Office of Research and Development.
NCT04581603 is a Phase 4 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 82 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04581603, a Phase 4 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study Summary
Alcohol Use Disorder (AUD) and insomnia are more prevalent in Veterans than in the general community. Furthermore, insomnia is comorbid in 36-91% of individuals with AUD and jeopardizes recovery by increasing their risk for relapse and complicating their clinical profile. The VA/DoD guidelines recommend four medications for the treatment of AUD by promoting abstinence and a reduction in drinking. Two of these medications (MED) used commonly are naltrexone and topiramate but they do not improve sleep continuity or insomnia. The recommended treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I), and it has shown efficacy in improving insomnia but with minimal benefit in improving abstinence. However, these studies have involved subjects in early or sustained remission. The proposed study will evaluate whether augmenting MED with CBT-I, after reducing drinking or achieving abstinence, bolsters recovery in AUD, by decreasing insomnia and improving abstinence. If this strategy shows good clinical results and the findings are replicated in a multi-center trial then the combination of MED with CBT-I should be considered a standard component of the initial management of AUD with insomnia.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
- BEHAVIORAL Sleep Hygiene Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2022-06-15 |
| Est. Completion | 2025-01-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04581603
The ClinicalTrials.gov registry entry for NCT04581603 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy for Insomnia is the first listed.
NCT04581603 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04581603 about?
NCT04581603 is a clinical study titled "CBT-I Augmentation of Medication for Drinking in AUD". Alcohol Use Disorder (AUD) and insomnia are more prevalent in Veterans than in the general community. Furthermore, insomnia is comorbid in 36-91% of individuals with AUD and jeopardizes recovery by increasing their risk for relapse and complicating their clinical profile. The VA/DoD guidelines recom...
What is the current status of trial NCT04581603?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2022-06-15. Estimated completion is 2025-01-20.
What interventions are being tested in trial NCT04581603?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL), Sleep Hygiene Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT04581603?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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