Status:
RECRUITING
Motivation for IV Alcohol Self-Administration in Humans
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
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 ...
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 mo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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"
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06494891
Start Date
January 16 2024
End Date
June 30 2027
Last Update
March 25 2025
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095