RecruitingNot Applicable

Sleep as a Mechanism of Change in Alcohol Use

United States256 participantsStarted 2024-03-02

Plain-language summary

This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.

Who can participate

Age range

18 Years – 49 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * report heavy drinking in a typical week in the past month * meet DSM-5 criteria for Alcohol Use Disorder * meet DSM-5 and research diagnostic criteria for Insomnia Disorder Exclusion Criteria: * ≥50 years * unable to provide informed consent * report contraindications for CBT-I (mania or seizure disorder) * moderate to severe sleep apnea that is untreated * have symptoms requiring immediate clinical attention (e.g., psychosis, suicide plan) * are already receiving behavioral treatment for insomnia or alcohol use

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insomnia Symptoms

Timeframe: Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

Drinking quantity

Timeframe: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

Alcohol-related consequences

Timeframe: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

Trial details

NCT IDNCT06286774

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-30

Contact for this trial

Mary Beth Miller Miller, PhD

573-882-1813 millmary@health.missouri.edu

View on ClinicalTrials.gov More Insomnia trials

Who can participate

Age range

18 Years – 49 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Insomnia Symptoms

Timeframe: Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

Drinking quantity

Timeframe: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups

Alcohol-related consequences

Timeframe: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups