Developing a new method to screen medications for Alcohol Use Disorder

Developing a Novel Human Laboratory Paradigm for AUD Medication Screening

This study is testing a new way to see how well people with Alcohol Use Disorder can resist drinking when faced with alcohol cues and rewards for not drinking.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06489782 on ClinicalTrials.gov

What this trial studies

This study aims to create two versions of a model that assesses the ability to resist drinking in individuals with Alcohol Use Disorder (AUD). The first model will evaluate how alcohol cues and availability affect participants' ability to resist drinking, while the second model will include a low dose prime to further examine this ability. Participants will undergo an intake session, a physical exam, and two laboratory sessions where they can choose to drink or receive monetary compensation for not drinking. The primary outcomes will focus on the latency to start drinking and the amount consumed during these sessions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-65 who meet the DSM-5 criteria for Alcohol Use Disorder and have a history of high alcohol consumption.

Not a fit: Patients with significant medical conditions or other substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective medications for treating Alcohol Use Disorder.

How similar studies have performed: While there have been studies on AUD treatments, this specific approach using a novel laboratory paradigm is relatively untested.

Eligibility criteria

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.

Where this trial is running

New Haven, Connecticut

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

Study contacts

• Principal investigator: Sherry McKee, PhD — Yale University
• Study coordinator: Meaghan Lavery

Conditions Alcohol Use Disorder