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NCT04457674 · ClinicalTrials.gov registry record · NA
Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)
A NA study of Alcohol Use Disorder and Insomnia, sponsored by University of Michigan.
- Active
- Registry status
- NA
- Development phase
- 134
- Enrollment target
- 1
- Study location
NCT04457674: Active NA study of Alcohol Use Disorder and Insomnia, sponsored by University of Michigan.
NCT04457674 is a NA study of Alcohol Use Disorder and Insomnia that is active but no longer recruiting, run by University of Michigan. The registered enrollment target is 134 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04457674, a NA study of Alcohol Use Disorder and Insomnia, is active but no longer recruiting, sponsored by University of Michigan.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 134 participants
- Enrollment target
- 1
- Study location
Study Summary
Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for alcohol use disorder.
Primary Outcome
The ISI is a 7-item self-report assessment of the nature, severity and impact of insomnia. Scores range from 0-28 with higher scores suggesting more clinically significant insomnia.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for insomnia (CBTi)
- BEHAVIORAL Sleep Hygiene Education (SHE)
Study Locations (1)
Michigan
- The University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2020-11-12 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What the registry record for NCT04457674 still lists
NCT04457674 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Behavioral Therapy for insomnia (CBTi) is the first listed.
NCT04457674 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04457674 about?
NCT04457674 is a clinical study titled "Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)". Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people ...
What is the current status of trial NCT04457674?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 134 participants. The study started on 2020-11-12. Estimated completion is 2026-03-31.
What conditions does trial NCT04457674 study?
This clinical trial studies the following conditions: Alcohol Use Disorder, Insomnia.
What interventions are being tested in trial NCT04457674?
The interventions under investigation include: Cognitive Behavioral Therapy for insomnia (CBTi) (BEHAVIORAL), Sleep Hygiene Education (SHE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04457674?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04457674 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04457674's enrollment target sits among peer trials
134 73rd of 184 higher than 112 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder 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.
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