Better sleep, less booze? new study tests phone therapy for insomnia and drinking
NCT ID NCT05973955
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests a phone-based sleep therapy for people who have insomnia and drink alcohol in ways that could harm their health. The therapy adapts standard insomnia treatment to also address alcohol-related thoughts and behaviors. Researchers will first refine the approach with a small group, then compare it to a simple education program in a randomized trial with 70 participants to see if it's feasible and promising enough for larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive Behavioral Therapy for Insomnia adapted for hazardous alcohol use (CBTi-HAU)
- What this could lead to
- If it works, this could lead to a practical, phone-based treatment that helps people with insomnia drink less alcohol.
- What could go wrong
- This is a very early, small study (70 people) focused on feasibility, not proof of effectiveness. The results may not apply to everyone, and the therapy may not reduce drinking more than simple education.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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70 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Aug 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * comprehension of written and spoken English (because we are developing and testing a new intervention for which translated materials are not available); * living in New York State (self-report); * Alcohol Use Disorder Identification Test (AUDIT) score of 8-15 to identify alcohol use that is in the hazardous zone; * current alcohol use (past 30 days) in excess of low-risk drinking guidelines as defined by U.S. Department of Health and Human Services and U.S. Department of Agriculture's 2015-2020 Dietary Guidelines for Americans using four items: items are 1) any use of alcohol; 2) the number of days that alcohol was used; 3) on days of alcohol use, the usual number of drinks; 4) number of days with 4/5 or more drinks on the same "occasion" defined as "at the same time or within a couple hours of each other". Based on these responses, we will determine if the individual exceeds low-risk drinking guidelines; * Insomnia Severity Index (ISI) score \> 8; and * meet Diagnostic and Statistical Manual of Mental Disorders (5th edition; \[DSM 5\]) criteria for Insomnia Disorder (this is evaluated by answers on the ISI supplemented by interview questions). Exclusion Criteria: * having received Cognitive Behavioral Therapy for Insomnia (by self-report and follow-up question prompts as needed); * current or recent (past year) professional alcohol treatment (from self-report and prompts), however, participants who only report beginning alcohol treatment during the follow-up period will not be excluded from completing any remaining follow-up assessments, but this will be recorded in the data and assessed as a potential covariate. * current or recent (past year) intravenous drug use or non-prescribed use of stimulant medications (e.g., cocaine, methamphetamines) (from TLFB and self-report question prompts); * hospice patients, patients undergoing oncology treatment, patients with a recent or upcoming surgery and/or endorsing a serious medical or psychiatric condition item from a conditions and medications form administered by the Assessor); * endorsing current suicidal ideation (past two weeks) with either a prior suicide attempt or being assessed at higher risk for suicide by the "P4 Screener" (a suicide risk screen used in both clinical settings and clinical trials); * current pregnancy or intent to become pregnant during the next 6 months or given birth in the past 3 months or currently breast-feeding; * significant sleep disorders other than insomnia such as narcolepsy or untreated sleep apnea with a Body Mass Index \> 32 (from self-report and the validated Sleep Disorders Questionnaire screening instrument) although those receiving care for sleep apnea, however, (e.g., positive airway pressure therapy) will be eligible; and * providing false information such as false name, contact information, or study responses.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Rochester Medical Center
Rochester, New York, 14642, United States
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Other studies related to the condition(s) this trial covers.
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