Alcohol Use DisorderPhase 2NCT06494891
Motivation for IV Alcohol Self-Administration in Humans
A Phase 2 study testing Intravenous Alcohol in people with Alcohol Use Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Intravenous Alcohol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 30 Jun 2027
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in the study, participants must:
- Be between the ages of 21 and 65
- Have self-reported alcohol use in the past 30 days
- Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder mild-to-severe
Who cannot join
- To be included in the study, participants must not:
- Currently be treatment seeking, in treatment for alcohol use, or have a history of treatment in the 30 days prior to consent
- Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder
- Have current suicidal ideation or lifetime history of suicide attempt as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Have a positive urine screen for drugs other than cannabis
Show all 25Show fewer
- 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
- 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)
- 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"
- Currently use any medications known to interact with alcohol, including: antidepressants, anticonvulsants, opioids, benzodiazepines, medications for diabetes, and medications that affect alcohol metabolism
- Have an intense fear of needles or have had adverse reactions to needle puncture
- Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation
- To participate in the IV alcohol administration, participants must not:
- Have a BrAC > 0.000 g/dl
- Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
- 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"
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
University of California, Los Angeles
Los Angeles, California, 90095
Jessica Jenkins, MS, 310-206-6756, jenkinsj@ucla.edu
Erica Grodin, PhD, 3102066756, egrodin@psych.ucla.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Intravenous Alcohol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous AlcoholDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Alcohol | Experimental | Participants will receive 6% ethanol v/v in saline administered intravenously through the physiologically based pharmacokinetic model implemented in the Computerized Alcohol Infusion System. Receives: Drug: Intravenous Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incentive Salience, Craving, and Self-Administration
Scores on the incentive salience factor of the ANA will correlate with craving during the challenge and self-administration during the progressive ratio.
Measured: 10 hours
Negative Emotionality, Negative Mood, and Self-Administration
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.
Measured: 10 hours
Executive Dysfunction, Loss of Control, and Self-Administration
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.
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start16 Jan 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (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 University of California, Los AngelesThe 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive intravenous alcohol.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lara Ray, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494891
- Sponsor's protocol ID
- #23-000434
- Other IDs
- 1R01AA029701-01
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data will be uploaded to the National Institute on Alcohol Abuse and Alcoholism Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Underpinnings of Motivation for Alcohol in Humans
- ClinicalTrials.gov ID
- NCT06494891
- Acronym / sponsor ID
- #23-000434
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 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 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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive intravenous alcohol.
| Arm | Type | Receives |
|---|---|---|
| Intravenous Alcohol | Experimental | Drug: Intravenous AlcoholParticipants will receive 6% ethanol v/v in saline administered intravenously through the physiologically based pharmacokinetic model implemented in the Computerized Alcohol Infusion System. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be between the ages of 21 and 65
- Have self-reported alcohol use in the past 30 days
- Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder mild-to-severe
Key exclusion criteria (25 listed)
- Currently be treatment seeking, in treatment for alcohol use, or have a history of treatment in the 30 days prior to consent
- Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder
- Have current suicidal ideation or lifetime history of suicide attempt as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Have a positive urine screen for drugs other than cannabis
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 |
|---|---|---|
| Intravenous AlcoholParticipants 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. | Drug | Intravenous Alcohol |
Primary outcome
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.
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.
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.
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 1 May 2026.
- Individual participant dataSharing planned: No. Deidentified data will be uploaded to the National Institute on Alcohol Abuse and Alcoholism Data Archive.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous Alcohol in people with Alcohol Use Disorder, run by University of California, Los Angeles 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 4 inclusion and 25 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 1 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jessica Jenkins, MS (310-206-6756, jenkinsj@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incentive Salience, Craving, and Self-Administration (time frame: 10 hours). The study lists 3 primary outcomes in all. 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 1 May 2026.