Status:
COMPLETED
An Inflammatory Challenge Using Endotoxin
Lead Sponsor:
University of California, Los Angeles
Conditions:
Alcohol Use Disorder
Inflammatory Response
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief Summary
The study design consists of a randomized, double-blind, placebo-controlled trial of low dose endotoxin. The low dose endotoxin challenge induces a transient systemic inflammatory response with normal...
Detailed Description
RECRUITMENT: Participants will be recruited from the community through online and newspaper advertisements. Campaigns in local buses and print publications (e.g., LA Weekly) will also be implemented. ...
Eligibility Criteria
Inclusion
- Be between the ages of 21 and 45
- Be non-treatment seeking for AUD
- Have had at least one alcoholic beverage in the last 30 days
- FOR HEAVY DRINKERS: Alcohol Use Disorder Identification Test (AUDIT) score between 8 - 15; FOR LIGHT DRINKERS: AUDIT score \< 4
- FOR HEAVY DRINKERS: Report drinking at binge levels at least 1 time in the past month (5+ drinks/day for men, 4+ drinks/day for women); FOR LIGHT DRINKERS: report no occasions of binge drinking in the past month
Exclusion
- Have a 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 psychotic disorder
- Have current moderate to severe depression as indicated by a score of ≥ 21 on the Beck Depression Inventory - II (BDI-II)
- 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;
- Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 8 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
- Have an intense fear of needles or have had any adverse reactions to needle puncture
- 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
- Complete abstinence from sexual intercourse
- Hormonal vaginal contraceptive ring
- Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes, autoimmune or inflammatory disease)
- Have clinically significant abnormal EKG
- Have \> Grade 2 laboratory abnormalities, based on FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"
- Have any other circumstances that, in the opinion of the investigators, compromises participant safety
- Have non-removable ferromagnetic objects in body
- Have claustrophobia
- Have serious head injury or prolonged period of unconsciousness (\>30 minutes)
- Exclusionary Criteria for Inflammatory Challenge Visits:
- BrAC \> 0.000 g/dl
- clinical withdrawal (CIWA-R) score ≥ 8
- blood pressure ≤ 90/60 or ≥ 160/120
- resting pulse ≤ 50 beats/minute or \> 100 beats/minute
- temperature ≥ 99.5°F
- recent (past 2 weeks) acute illness or vaccination
- score of 10+ on Physical Sickness Symptoms Assessment
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04310423
Start Date
October 19 2021
End Date
November 14 2023
Last Update
May 1 2025
Active Locations (1)
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1
UCLA Addictions Laboratory
Los Angeles, California, United States, 90095