Developing a Novel Human Laboratory Paradigm for AUD Medication Screening

Last updated: February 12, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alcohol Use Disorder

Addictions

Alcohol Dependence

Treatment

Model 2

Model 1

Clinical Study ID

NCT06489782
2000037693
  • Ages 21-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 dayat least once per week; Females -Drinks > 14 drinks per week and exceeds 3 drinksper day at least once per week. Must meet drinking criteria during 30-day periodprior to baseline; 6) Laboratory sessions will be scheduled such that participantswill not have major responsibilities on the following day which might limit drinkingduring the self-administration session (e.g., job interview, exam).

Exclusion

Exclusion Criteria:

  1. Participants with any significant current medical conditions (neurological,cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium orhallucinations, or other unstable medical conditions including HIV;

  2. Current DSM-5 substance use disorder (other than AUD or tobacco use disorder or mildcannabis dependence);

  3. A positive test result at intake appointment on urine drug screens conducted forillicit drugs;

  4. Women who are pregnant or nursing, or fail to use one of the following methods ofbirth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptivesponge, double barrier [diaphragm or condom plus spermicide], or IUD);

  5. Suicidal, homicidal or evidence of current (past 6-month) diagnosis ofschizophrenia, or bipolar disorder, or psychosis. Participants diagnosed withpsychiatric disorders not specifically listed above may be included at thediscretion of the study MD as long as the concurrent treatment for the comorbidpsychiatric 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 thestudy. Specifically, we will exclude participants who a) have a history ofperceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b)have a score of > 8 on the Clinical Institute Withdrawal Assessment scale at intakeappointments;

  8. Individuals who are currently treatment for drinking or who have attempted to quitdrinking within the past 3 months in order to exclude participants seekingtreatment;

  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 bloodsampling and/or interventional measures that would be considered excessive incombination with the current study.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Model 2
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
June 30, 2026

Study 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 the 'ability to resist' drinking and subsequent ad-lib drinking. Model 2 (alcohol cues & alcohol availability + low dose prime) on the 'ability to resist' drinking and subsequent ad-lib drinking.

This study will consist of an intake session, a physical exam, and two laboratory sessions. Each laboratory session will start with the presentation of the primes for Model 1 or 2, following which, participants will have the option of initiating an alcohol self-administration session or delaying initiation by five-minute increments for up to 50 minutes in exchange for monetary reinforcement. Subsequently, the alcohol self-administration session entails a 2-hour period in which participants can choose to drink their preferred beverage or receive monetary compensation for alcohol not consumed.

The primary outcome measures for Aim 1 is the latency to start drinking (i.e., ability to resist drinking) and amount consumed during the self-administration sessions.

Connect with a study center

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

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