Status:
ACTIVE_NOT_RECRUITING
Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Insomnia
Alcohol Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 diso...
Eligibility Criteria
Inclusion
- Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 months of abstinence
- Planned enrollment into an abstinence-based treatment program
- Meet probable DSM-5 criteria for chronic insomnia
- Access to a video chat-capable device and reliable Wi-Fi network
Exclusion
- Diagnosis of, or high suspicion for, sleep disorders other than insomnia
- 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
Key Trial Info
Start Date :
November 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2026
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04457674
Start Date
November 12 2020
End Date
February 28 2026
Last Update
November 13 2025
Active Locations (1)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109