Motivation for IV Alcohol Self-Administration in Humans

NCT06494891 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: #23-0004341R01AA029701-01
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  10 hours

Study Arms (1)

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.

Drug: Intravenous Alcohol

Interventions

Intravenous Alcohol DRUG

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.

Intravenous Alcohol

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Jessica Jenkins, MS

CONTACT

310-206-6756; jenkinsj@ucla.edu

Erica Grodin, PhD

CONTACT

310-206-6756; egrodin@psych.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants will receive intravenous alcohol.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: January 16, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)