CompletedNot Applicable

Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality

United States96 participantsStarted 2020-06-29

Plain-language summary

State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients suffering from alcohol use disorder (AUD). The specific AIMS will be: 1. To determine the effectiveness of Soberlink's ability to increase abstinence 2. To evaluate the impact of Soberlink's device on the participant based on their quality of health and sobriety. 3. To evaluate the extent to which need for higher levels of follow-up care and treatment is reduced for individuals who have had access to the Soberlink device.

Who can participate

Age range

21 Years – 60 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: * are at least 21 years old, * currently enrolled at Aware In home treatment, * Primary or secondary DSM-5 diagnosis of alcoholism use disorder (AUD). Exclusion Criteria: * Current suicide or homicide risk, * meet criteria for DSM-IV current psychotic disorder, or bipolar disorder, * does not have phone access with text message capabilities * Unable to read or understand English, * Unable to complete the study because of anticipated incarceration or move, * Life-threatening or unstable medical problems, * No course of current or pending legal action, * Soberlink results being used for child custody or legal circumstance.

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

Alcohol Time Line Follow Back (TLFB)

Timeframe: up to 24 weeks

Trial details

NCT IDNCT04380116

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-01

Results submitted2023-04-27

View on ClinicalTrials.gov More Alcohol Use Disorder trials