InsomniaNCT04457674
Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)
A study testing Cognitive Behavioral Therapy for insomnia (CBTi) and Sleep Hygiene Education (SHE) in people with Insomnia and Alcohol Use Disorder, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Alcohol Use Disorder
- What is being tested?
- Cognitive Behavioral Therapy for insomnia (CBTi) and Sleep Hygiene Education (SHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2020to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes
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.
- Conditions
- Insomnia, Alcohol Use Disorder
- Being tested
- Cognitive Behavioral Therapy for insomnia (CBTi), Sleep Hygiene Education (SHE)
- Keywords
- Cognitive Behavioral Therapy, Sleep Hygiene
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Alcoholism, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for insomnia (CBTi)Behavioural
CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Sleep Hygiene Education (SHE)Behavioural
SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBTi) | Other | CBTi is a non-medication therapy that includes cognitive and behavioral treatment components. Receives: Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi) |
| Sleep Hygiene Education (SHE) | Other | SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep. Receives: Behavioral: Sleep Hygiene Education (SHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score from the insomnia severity index (ISI)
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.
Measured: Immediately post treatment
Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)
The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption.
Measured: Immediately post treatment
Secondary outcomes (1)
Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale
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.
Measured: Immediately post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start12 Nov 2020
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, J. Todd Arnedt, University of Michigan
- Investigators
- J Todd Arnedt, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457674
- Sponsor's protocol ID
- HUM00173631
- Other IDs
- R01AA028158
- Status last verified
- May 2026
- First submitted
- 29 Jun 2020
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared through the National Institute of Mental Health (NIMH) Data Archive. Only information relevant to the research project will be shared, which may include demographic information such as gender and age, responses to surveys and results found from the research project. Participants identifying data will not be shared in any way and information related to participants will be given a different random identifier known as a Global Unique Identifier or GUID. This number will not coincide with any identifier for data stored on University of Michigan study databases.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes
- ClinicalTrials.gov ID
- NCT04457674
- Acronym / sponsor ID
- HUM00173631
- Conditions
- Insomnia, Alcohol Use Disorder
- Keywords
- Cognitive Behavioral Therapy, Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBTi) | Other | Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi)CBTi is a non-medication therapy that includes cognitive and behavioral treatment components. |
| Sleep Hygiene Education (SHE) | Other | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBTi)CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine. | Behavioural | Cognitive Behavioral Therapy for insomnia (CBTi) |
| Sleep Hygiene Education (SHE)SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine. | Behavioural | Sleep Hygiene Education (SHE) |
Primary outcome
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.
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.
1 secondary outcome
Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale
Time frame: Immediately post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared through the National Institute of Mental Health (NIMH) Data Archive. Only information relevant to the research project will be shared, which may include demographic information such as gender and age, responses to surveys and results found from the research project. Participants identifying data will not be shared in any way and information related to participants will be given a different random identifier known as a Global Unique Identifier or GUID. This number will not coincide with any identifier for data stored on University of Michigan study databases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Todd Arnedt, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for insomnia (CBTi) and Sleep Hygiene Education (SHE) in people with Insomnia and Alcohol Use Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score from the insomnia severity index (ISI) (time frame: Immediately post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.