New lab model aims to speed up alcoholism drug screening
NCT ID NCT06489782
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to create a lab-based test to help screen medications for Alcohol Use Disorder (AUD). Researchers will observe how 90 adults with AUD resist drinking in a controlled setting. The goal is to develop a reliable method to test new treatments, not to provide direct therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: 1. Provision of signed and dated informed consent form; 2. Male or Female Age 21-65; 3. Able to read and write English; 4. Meets DSM-5 criteria for current (past 6 months); 5. 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: 1. Participants with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV; 2. Current DSM-5 substance use disorder (other than AUD or tobacco use disorder or mild cannabis dependence); 3. A positive test result at intake appointment on urine drug screens conducted for illicit drugs; 4. 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); 5. Suicidal, homicidal or evidence of current (past 6-month) diagnosis of schizophrenia, or bipolar disorder, or psychosis. Participants diagnosed with psychiatric disorders not specifically listed above may be included at the discretion of the study MD as long as the concurrent treatment for the comorbid psychiatric condition does not compromise the study integrity by virtue of its type, duration, or intensity; 6. Only one member per household can participate in the study; 7. Participants likely to exhibit clinically significant alcohol withdrawal during the study. Specifically, we will exclude participants who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments; 8. Individuals who are currently treatment for drinking or who have attempted to quit drinking within the past 3 months in order to exclude participants seeking treatment; 9. Participants who have taken any investigational drug within 4 weeks of intake; 10. Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yale University
RECRUITINGNew Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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