Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Better sleep, less booze? new study tests phone therapy for insomnia and drinking

NCT ID NCT05973955

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

70 people

The number who actually took part.

Started

Mar 2024

Finished

Aug 2026

Lead sponsor

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

25 to 64 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Harmful; use, alcohol are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.