RecruitingNot Applicable

Developing a Novel Human Laboratory Paradigm for AUD Medication Screening

United States90 participantsStarted 2024-11-01

Plain-language summary

The intent of the study is to develop two versions of the 'ability to resist' drinking model designed to screen Alcohol Use Disorder (AUD) medications.

Who can participate

Age range

21 Years – 65 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

. Provision of signed and dated informed consent form;
. Male or Female Age 21-65;
. Able to read and write English;
. Meets DSM-5 criteria for current (past 6 months);
. Drinking criteria: Males - Drinks \> 28 drinks per week and exceeds 4 drinks per day at least once per week; Females -Drinks \> 14 drinks per week and exceeds 3 drinks per day at least once per week. Must meet drinking criteria during 30-day period prior to baseline; 6) Laboratory sessions will be scheduled such that participants will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam).

Exclusion criteria

. Participants with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV;
. Current DSM-5 substance use disorder (other than AUD or tobacco use disorder or mild cannabis dependence);
. A positive test result at intake appointment on urine drug screens conducted for illicit drugs;
. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD);

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 consumption

Timeframe: 120 minutes

Trial details

NCT IDNCT06489782

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Meaghan Lavery

203-737-2783 meaghan.lavery@yale.edu

View on ClinicalTrials.gov More Alcohol Use Disorder trials