Alcohol Use DisorderNCT06489782
Developing a Novel Human Laboratory Paradigm for AUD Medication Screening
A study testing Model 1 and Model 2 in people with Alcohol Use Disorder, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Model 1 and Model 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06510
Meaghan Lavery, 203-737-2783, meaghan.lavery@yale.edu
Sabrina Coppola, 203-737-2827, sabrina.coppola@yale.edu
About this study
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.
Read the 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 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Model 1, Model 2
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model 1Other
Model 1 examines the impact of alcohol cues and alcohol availability on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period.
Model 2Other
Model 2 examines the impact of alcohol cues and alcohol availability and a priming dose of alcohol (.04 g/dL) on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period.
| Study group | Role | What they receive |
|---|---|---|
| Model 1 | Experimental | Model 1 examines the impact of alcohol cues and alcohol availability on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period. Receives: Other: Model 1; Other: Model 2 |
| Model 2 | Experimental | Model 2 examines the impact of alcohol cues and alcohol availability and a priming dose of alcohol (.04 g/dL) on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period. Receives: Other: Model 1; Other: Model 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Means mls of alcohol consumed during 120 minute alcohol self-administration sessions
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Nov 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherry McKee, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489782
- Sponsor's protocol ID
- 2000037693
- Status last verified
- May 2026
- First submitted
- 28 Jun 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Novel Human Laboratory Paradigm for AUD Medication Screening
- ClinicalTrials.gov ID
- NCT06489782
- Acronym / sponsor ID
- 2000037693
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model 1 | Experimental | Other: Model 1, Other: Model 2Model 1 examines the impact of alcohol cues and alcohol availability on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period. |
| Model 2 | Experimental | Other: Model 1, Other: Model 2Model 2 examines the impact of alcohol cues and alcohol availability and a priming dose of alcohol (.04 g/dL) on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Model 1Model 1 examines the impact of alcohol cues and alcohol availability on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period. | Other | Model 1, Model 2 |
| Model 2Model 2 examines the impact of alcohol cues and alcohol availability and a priming dose of alcohol (.04 g/dL) on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period. | Other | Model 1, Model 2 |
Primary outcome
Alcohol consumption
Time frame: 120 minutes
Means mls of alcohol consumed during 120 minute alcohol self-administration sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sherry McKee, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model 1 and Model 2 in people with Alcohol Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meaghan Lavery (203-737-2783, meaghan.lavery@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.