Scientists to inflame Drinkers' bodies to uncover craving triggers
NCT ID NCT07452146
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study aims to understand how inflammation in the body influences mood and alcohol cravings in people with alcohol use disorder (AUD). Researchers will give 64 participants (32 with AUD and 32 without) a single low dose of a substance that causes temporary inflammation or a placebo. They will then measure mood, cravings, and blood markers to see if inflammation plays a role in drinking behavior.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (AUD Group): 1. Be between the ages of 21 and 65 2. Meet current (i.e., past month) DSM-5 diagnostic criteria for moderate to severe AUD 3. Alcohol use disorder identification test (AUDIT) score \<20 4. Be non-treatment seeking for AUD 5. Report drinking more than 14 drinks per week if male (more than 7 drinks per week if female) in the 30 days prior to consent. 6. 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 Inclusion Criteria (Control Group): 1. Be between the ages of 21 and 65 2. No lifetime history (i.e., past year) DSM-5 diagnostic criteria for AUD 3. Alcohol use disorder identification test (AUDIT) score \<8 4. Report drinking at or below moderate drinking levels (≤7 drinks/week for females, ≤14 drinks/week for males) in the 30 days prior to consent. 5. 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 Exclusion Criteria (All Groups): 1. Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine 2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, major depressive disorder, or any psychotic disorder 3. Have current moderate to severe depression as indicated by a score of ≥ 21 on the Beck Depression Inventory - II (BDI-II) 4. Have current suicidal ideation or lifetime history of suicide attempt as reported onvthe Columbia-Suicide Severity Rating Scale (C-SSRS) 5. Have a positive urine screen for drugs other than cannabis; 6. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 8 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R) 7. Have an intense fear of needles or have had any adverse reactions to needle puncture 8. Be pregnant, nursing, or planning to become pregnant while taking part in the study 9. Have a body mass index (BMI) greater than 30 10. 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) 11. Have clinically significant abnormal EKG 12. 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" 13. Have any other circumstances that, in the opinion of the investigators, compromises participant safety To participate in the inflammatory challenge, participants must not show any of the following upon arrival to the inflammatory challenge study visit: 1. BrAC \> 0.000 g/dl 2. clinical withdrawal (CIWA-R) score ≥ 8 3. blood pressure ≤ 90/60 or ≥ 160/120 4. resting pulse ≤ 50 beats/minute or \> 100 beats/minute 5. temperature ≥ 99.5°F 6. recent (past 2 weeks) acute illness or vaccination 7. score of 10+ on Physical Sickness Symptoms Assessment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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