Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)
NCT ID: NCT04457674
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
131 participants
INTERVENTIONAL
2020-11-15
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cognitive Behavioral Therapy for insomnia (CBTi)
CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.
Cognitive Behavioral Therapy for insomnia (CBTi)
CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Sleep Hygiene Education (SHE)
SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.
Sleep Hygiene Education (SHE)
SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Interventions
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Cognitive Behavioral Therapy for insomnia (CBTi)
CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Sleep Hygiene Education (SHE)
SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Eligibility Criteria
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Inclusion Criteria
* Planned enrollment into an abstinence-based treatment program
* Meet probable DSM-5 criteria for chronic insomnia, confirmed with sleep diary
* Ability to travel to Ann Arbor for sleep laboratory assessments
* Access to a video chat-capable device and reliable Wi-Fi network
Exclusion Criteria
* Meet probable DSM-5 criteria for bipolar disorder, psychotic disorder, or post-traumatic stress disorder (PTSD)
* Terminal or progressive physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia), or presence of an unstable medical condition that is the specific cause of insomnia
* Self-reported pregnancy or intention to become pregnant during the study
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of Michigan
OTHER
Responsible Party
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J. Todd Arnedt
Associate Professor of Psychiatry
Principal Investigators
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J Todd Arnedt, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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The University of Michigan
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HUM00173631
Identifier Type: -
Identifier Source: org_study_id