Recruiting
Phase 2

Alcohol Self-Administration

Sponsor:

UCLA

Code:

NCT06494891

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Intravenous Alcohol

Study Details

Brief 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. 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.

Conditions

Alcohol Use Disorder

Study ID

NCT06494891

Start date

Jan 16, 2024

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

210 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Incentive Salience, Craving, and Self-Administration [ Time Frame: 10 hours ]
  • Negative Emotionality, Negative Mood, and Self-Administration [ Time Frame: 10 hours ]
  • Executive Dysfunction, Loss of Control, and Self-Administration [ Time Frame: 10 hours ]

Central Contacts and Locations

Central contacts

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Lara Ray, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-05-01.