Understanding motivations for self-administering alcohol in people with alcohol use disorder

Translational Underpinnings of Motivation for Alcohol in Humans

This study is trying to understand why people with alcohol use disorder choose to drink alcohol by looking at their feelings, thoughts, and reactions while they self-administer alcohol in a controlled setting.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06494891 on ClinicalTrials.gov

What this trial studies

This study aims to explore the motivations behind alcohol self-administration in individuals aged 21 to 65 with alcohol use disorder. Participants will undergo intravenous alcohol administration followed by a progressive ratio self-administration task, where they will press a button to receive doses of alcohol. The study will assess how factors such as desire for reward, emotions, and cognitive functioning influence their motivation to consume alcohol. Additionally, participants will complete questionnaires and provide blood samples for biomarker analysis related to stress and inflammation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 65 who have a current diagnosis of alcohol use disorder and have consumed alcohol in the past 30 days.

Not a fit: Patients who are currently seeking treatment for alcohol use or have a history of treatment in the past 30 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for individuals with alcohol use disorder.

How similar studies have performed: Other studies have explored motivations for alcohol use, but this specific approach combining intravenous administration and progressive ratio self-administration is relatively novel.

Eligibility criteria

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"

Where this trial is running

Los Angeles, California

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

Study contacts

• Study coordinator: Jessica Jenkins, MS

Conditions Alcohol Use Disorder