CompletedNot Applicable

A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults

United States60 participantsStarted 2022-02-23

Plain-language summary

Heavy alcohol use among young adults is a significant public health problem. Advances in technology may offer an innovative solution. This project will conduct the first controlled test of a feedback intervention for reducing drinking and improving health in young adults by targeting heart rate variability, resting heart rate, and sleep via biosensors and electronic diary methods.

Who can participate

Age range

18 Years – 25 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: * 18-25 years of age * Report ≥ 4 heavy drinking occasions in the past 28 days * Report Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) scores indictive of risk of drinking harm * English Speaking * Have a personal smartphone Exclusion Criteria: * Sleep Disorder History * Night/ Rotating work shift * Travel two or more time zones in the month prior to the study or anticipated travel two or more times during study participation * Clinically severe AUD in past 12 months * Currently enrolled in alcohol or sleep treatment * Current, severe psychiatric illness * Current DSM-V substance use disorder * Positive urine drug screen for a substance other than marijuana

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

Total Drinks Consumed

Timeframe: up to Week 10

Trial details

NCT IDNCT05090995

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-01

Results submitted2024-05-30

View on ClinicalTrials.gov More Heavy Drinking trials