Motivation for IV Alcohol Self-Administration in Humans

Recruiting now · Phase 2

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT06494891

Run by

University of California, Los Angeles

People needed

210

Starts

2024-01-16

Expected to finish

2027-06-30

Last updated by the study team

2026-05-01

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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
• Exclusion Criteria for Experimental Visit
• 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)

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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