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ACTIVE NOT RECRUITING NA

Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)

NCT04457674 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 134 participants
Start Date 2020-11-12
Est. Completion 2026-03-31
Phase NA

Sponsor

University of Michigan

1,126 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04457674

The ClinicalTrials.gov registry entry for NCT04457674 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,126 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04457674 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04457674?

This trial is sponsored by University of Michigan, which has 1,126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial