Skip to main content
OpenTrials
Completed

NCT Number: NCT04457674

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 also in treatment for alcohol use disorder.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Dyssomnias Health Behavior Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

Treatment and study plan

Cognitive Behavioral Therapy for insomnia (CBTi)

Behavioral

CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.

Sleep Hygiene Education (SHE)

Behavioral

SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.

Primary outcomes

  1. Score from the insomnia severity index (ISI)

    Time frame: Immediately post treatment

    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.

  2. Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)

    Time frame: Immediately post treatment

    The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption.

Secondary outcomes

  1. Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale

    Time frame: Immediately post treatment

    The MFI is a 20-item assessment that provides an overall fatigue score (20-100) in addition to 5 separate dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Sub-scale scores range from 4-20 with higher scores indicating higher levels of fatigue.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2020
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.