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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). 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.
Primary Outcome
Insomnia Severity Index (ISI): This 7-item (0-4 Likert scales) measure yields a total score of 28. The norms for the scale are as follows: 0-7 represents no clinically significant insomnia; 8-14 represents sub threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The scale provides a measure of severity of insomnia (overall), a measure of insomnia subtype, a measure of the diurnal effects of insomnia, and a measure of sleep "sati
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 |
Why NCT04581603 stopped before completion
NCT04581603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy for Insomnia is the first listed.
NCT04581603 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04581603's enrollment target sits among peer trials
82 939th of 2000 higher than 1,061 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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