Motivation for IV Alcohol Self-Administration in Humans

April 27, 2026 updated by: Lara Ray, PhD, University of California, Los Angeles

Translational Underpinnings of Motivation for Alcohol in Humans

The goal of this translational study is to understand different reasons why people between the ages of 21 and 65 with alcohol use disorder are motivated to self-administer alcohol. The main questions it aims to answer are:

  • How does a person's desire for a reward affect their motivation to self-administer alcohol?
  • How does a person's emotions affect their motivation to self-administer alcohol?
  • How does a person's cognitive functioning affect their motivation to self-administer alcohol?

Participants will be asked to complete questionnaires about their mood, habits, and functioning and will complete an IV alcohol administration that will include pressing a button to receive additional doses of IV alcohol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study combines alcohol challenge and progressive ratio self-administration methodologies to test the effects of each of the three dimensions of the Addictions Neuroclinical Assessment (ANA) on motivation for alcohol use. The experimental design consists of a translational study in which 210 individuals with current AUD (mild-to-severe) will complete an intravenous (IV) alcohol administration followed by a progressive ratio self-administration paradigm, where participants must press a button a number of times to receive an infusion of alcohol. All participants will be phenotyped for the three dimensions of the ANA, including incentive salience, negative emotionality, and executive dysfunction. For these models, the primary outcome in the progressive ratio self-administration paradigm will be: (a) breakpoint (i.e., the point in the progressive ratio model at which the participant stops button presses for alcohol) and (b) peak BrAC (i.e., the highest level of BrAC reached in the trial). At baseline and after the target BrAC of 0.06 g/dl in the alcohol challenge component of the paradigm, participants will report on (a) alcohol craving, (b) negative mood, and (c) loss of control over drinking. All participants will provide blood samples at baseline and at target BrAC =0.06 g/dl for analyses of the proposed exploratory biomarkers of HPA axis activation (ACTH, cortisol) and inflammation (IL-6, IL-10, TNF-α, CRP). The successful completion of this project will advance translational science of AUD by testing the ANA framework within a conceptually rich and valid translational task of motivation for alcohol in humans. Advanced data analytic methods (i.e., machine learning) and careful attention to AUD severity as a marker to AUD stage, will result in clinically useful findings that can inform AUD assessment, treatment, and biomarker development.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Contact:
        • Principal Investigator:
          • Lara Ray, PhD
        • Contact:
        • Principal Investigator:
          • Erica Grodin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

To be included in the study, participants must:

  1. Be between the ages of 21 and 65
  2. Have self-reported alcohol use in the past 30 days
  3. Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder mild-to-severe

Exclusion Criteria:

To be included in the study, participants must not:

  1. Currently be treatment seeking, in treatment for alcohol use, or have a history of treatment in the 30 days prior to consent
  2. Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
  3. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder
  4. Have current suicidal ideation or lifetime history of suicide attempt as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS)
  5. Have a positive urine screen for drugs other than cannabis

  6. Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:

    • Oral contraceptives
    • Contraceptive sponge
    • Patch
    • Double barrier
    • Intrauterine contraceptive device
    • Etonogestrel implant
    • Medroxyprogesterone acetate contraceptive injection
    • Hormonal vaginal contraceptive ring
    • Complete abstinence from sexual intercourse
  7. Have clinically significant abnormalities identified in the physical exam that may interfere with safe study participation (e.g. unstable cardiac, renal, or liver disease; diabetes; uncontrolled hypertension; or HIV)
  8. Exceed Grade 2 laboratory abnormalities, based on FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"
  9. Currently use any medications known to interact with alcohol, including: antidepressants, anticonvulsants, opioids, benzodiazepines, medications for diabetes, and medications that affect alcohol metabolism
  10. Have an intense fear of needles or have had adverse reactions to needle puncture
  11. Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation

Exclusion Criteria for Experimental Visit

To participate in the IV alcohol administration, participants must not:

  1. Have a BrAC > 0.000 g/dl
  2. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
  3. Exceed Grade 2 clinical vital sign abnormalities, based on FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intravenous Alcohol
Participants will receive 6% ethanol v/v in saline administered intravenously through the physiologically based pharmacokinetic model implemented in the Computerized Alcohol Infusion System.
Drug: Intravenous Alcohol
Participants will receive intravenous alcohol (6% ethanol v/v in saline; obtained from the Ronald Reagan UCLA Medical Center Investigational Drug Service) over the course of an alcohol challenge. During the challenge, participants will be administered alcohol designed to reach target BrACs of 20, 40, and 60 mg%, each over 15 min. After reaching the last target BrAC (0.06 g/dl) participants will complete a self-administration (SA) paradigm. Participants will be invited to work (button press) for alcohol according to a log-linear progressive ratio schedule.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incentive Salience, Craving, and Self-Administration
Time Frame: 10 hours
Scores on the incentive salience factor of the ANA will correlate with craving during the challenge and self-administration during the progressive ratio.
10 hours
Negative Emotionality, Negative Mood, and Self-Administration
Time Frame: 10 hours
Scores on the negative emotionality factor of the ANA will correlate with relief from negative mood during the challenge and self-administration during the progressive ratio.
10 hours
Executive Dysfunction, Loss of Control, and Self-Administration
Time Frame: 10 hours
Scores on the executive dysfunction factor of the ANA will correlate with loss of control during the challenge and self-administration during the progressive ratio.
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #23-000434
  • 1R01AA029701-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified data will be uploaded to the National Institute on Alcohol Abuse and Alcoholism Data Archive.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings