Developing a Novel Human Laboratory Paradigm for AUD Medication Screening

Recruiting now · Not applicable

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT06489782

Run by

Yale University

People needed

90

Starts

2024-11-01

Expected to finish

2026-08-31

Last updated by the study team

2026-05-22

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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);
• 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;
• Only one member per household can participate in the study;
• 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;
• 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;
• Participants who have taken any investigational drug within 4 weeks of intake;
• 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.

Where it is running

• Yale University — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.