Status:
RECRUITING
Developing a Novel Human Laboratory Paradigm for AUD Medication Screening
Lead Sponsor:
Yale University
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief 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.
Detailed Description
Proposed is the development of two versions of the 'ability to resist' drinking model designed to screen AUD medications. Model 1 will examine the impact of alcohol cues and alcohol availability on th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06489782
Start Date
November 1 2024
End Date
June 30 2026
Last Update
July 29 2025
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06510