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

University of Michigan logo

University of Michigan

Status

Enrolling

Conditions

Insomnia
Alcohol Use Disorder

Treatments

Behavioral: Sleep Hygiene Education (SHE)
Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04457674
R01AA028158 (U.S. NIH Grant/Contract)
HUM00173631

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 weeks of abstinence
  • 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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups

Cognitive Behavioral Therapy for insomnia (CBTi)
Other group
Description:
CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.
Treatment:
Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi)
Sleep Hygiene Education (SHE)
Other group
Description:
SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.
Treatment:
Behavioral: Sleep Hygiene Education (SHE)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Libby Cardoni

Data sourced from clinicaltrials.gov

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