A Phase 2 interventional study of Endotoxin and Placebo saline in Alcohol Use Disorder, Inflammatory Response and Craving, sponsored by University of California, Los Angeles. Not yet recruiting. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by University of California, Los Angeles · Phase 2, Interventional, and Diagnostic
Among 19 studies in Alcoholism by University of California, Los Angeles — 3 open to participants now, 5 under way, 1 of them phase 3. Alcoholism · University of California, Los Angeles.
Among the 19 studies in Alcoholism by University of California, Los Angeles, this one is the 8th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2026, is one of 9 in phase 2, and was the 19th registered.
1,676 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
Browse Alcoholism studies →3 of the 19 studies in Alcoholism by University of California, Los Angeles are open now, in 1 country. Recruiting first, the newest first:
University of California, Los Angeles · Sites in United States
Ages 18+ · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 21–65
By country, each count listing its studies:
Of the 237 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 131 (55%) stop at 75 or younger; 9 take children under 18; 64 take healthy volunteers.
This study: 21 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 2
First in 2007; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 64 is below the median of 88 across 1,430 interventional studies indexed under Alcoholism.
Median enrollment 56 across the 17 interventional studies, 945 across the 2 observational. Of the 12 that completed or were terminated, 7 (58%) have results posted.
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University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
1 of the studies in Alcoholism by University of California, Los Angeles that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06494891University of California, Los AngelesMotivation for IV Alcohol Self-Administration in Humans | 2027-04-30 |
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Among the 19 studies in Alcoholism by University of California, Los Angeles, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The study design consists of a randomized, double-blind, placebo-controlled study of low dose endotoxin. Individuals with current AUD (n=32) and matched controls without AUD (n=32) will be randomly assigned to receive a single intravenous (I.V.) infusion of either low dose endotoxin (0.8 ng/kg of body weight) or placebo (same volume of 0.9% saline solution) to determine the acute and protracted role of inflammation in alcohol use.
Participants will be recruited from the community through campaigns in radio, buses, social media, and print publications. After a telephone interview, eligible individuals will complete in-person screening to assess for presence of DSM-5 alcohol use disorder and additional inclusion/exclusion criteria. Eligible participants will complete a physical exam to assess medical safety, including EKG and laboratory tests. Participants who pass the physical exam will then be randomized to an experimental condition (i.e., endotoxin vs. placebo). Randomization will be stratified by sex (male versus female) and AUD (moderate versus severe). Participants will complete an alcohol cue-exposure paradigm in the lab 2 hours post infusion, the time of peak cytokine response. Plasma levels of inflammatory cytokines (i.e., interleukin-6 (IL-6) and tumor necrosis factor-α (TNF- α)), mood, and alcohol craving, will be assessed at baseline and then hourly for four hours post infusion. Following the infusion, all participants will complete a 14-day follow-up phase consisting of daily diary surveys of mood, alcohol craving, and alcohol consumption. The adverse events will be managed by study nurse practitioners during the endotoxin challenge.
Inclusion Criteria (AUD Group):
Must agree to one of the following methods of (if female), unless she or partner are surgically sterile:
Inclusion Criteria (Control Group):
Must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:
Exclusion Criteria (All Groups):
To participate in the inflammatory challenge, participants must not show any of the following upon arrival to the inflammatory challenge study visit:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with alcohol use disorder vs. control who receive a bolus dose of endotoxin (0.8 ng/kg of body weight).
Drug: Endotoxin
Individuals with alcohol use disorder vs. control matched to endotoxin at same volume of 0.9% saline solution.
Other: Placebo saline
Bolus dose of 0.8 ng/kg
Also known as: Lipopolysaccharide
Matched to endotoxin
Acute Phase: To determine the effect of acute inflammation on mood in AUD versus controls.
The Profile of Mood States (POMS) is a self-report questionnaire that measures dimensions of mood. Four items from the POMS were summed to calculate the negative mood subscale. The items included "discouraged," downhearted," "uneasy," and "anxious." Participants rated the extent that they felt items "right now" on a scale from 0-4, with higher scores indicating more endorsement of the items. Items were summed to calculate negative mood subscale with the score ranging from 0-16, with higher scores indicating higher negative mood. The investigators were interested in whether low dose endotoxin would increase negative mood as compared to placebo in AUD vs control.
Time frame: Mood will be collected at baseline (prior to infusion) and hourly for 4 hours post-infusion.
Acute Phase: To determine the effect of acute inflammation on cue-reactivity in AUD versus controls.
Alcohol Urge Questionnaire (AUQ) score is the primary outcome for the cue-reactivity paradigm. The AUQ is comprised of eight items rated on a 7-point Likert scale with items related to the subjective experience of alcohol craving. The minimum value is 8 and the maximum value is 56 with a higher score indicating greater subjective alcohol craving. Phasic craving for alcohol following alcohol cue exposure was assessed using the first and last items from the AUQ during an alcohol cue reactivity paradigm at baseline and at time of expected peak cytokine response (T2). This subscale of 2 items about desire to drink rated on a 7-point Likert scale provided a minimum possible value of 2 and a maximum value of 14, with higher values indicating a higher craving to drink alcohol. The investigators are primarily interested in whether low dose endotoxin increases cue-induced craving for alcohol relative to placebo in AUD vs control.
Time frame: The cue-reactivity paradigm is conducted at baseline and at 2 hours post-infusion during the experimental visit.
Acute Phase: To determine the effect of acute inflammation on biomarkers in AUD versus controls.
Plasma levels of inflammatory cytokines Interleukin-6 (IL-6), IL-8, and tumor necrosis factor-α (TNF- α) will be collected at baseline and hourly timepoints post-infusion for 6 hours. The investigators are primarily interested in whether low dose endotoxin increases peripheral cytokines relative to placebo in AUD vs control.
Time frame: Blood samples will be collected at baseline (prior to infusion) and hourly for 4 hours post-infusion.
Follow-up Phase: To determine the protracted effects of acute inflammation on self-reported craving and alcohol use in AUD versus controls.
Individuals will complete a 14-day follow-up after the infusion visit consisting of daily diary online questionnaires to assess protracted endotoxin-induced effects on alcohol craving (Alcohol Urge Questionnaire (AUQ)) and alcohol consumption.
Time frame: 14-day follow-up phase after acute infusion visit.
Follow-up Phase: To determine the protracted effects of acute inflammation on mood in AUD versus controls.
Individuals will complete a 14-day follow-up after the infusion visit consisting of daily diary online questionnaires to assess protracted endotoxin-induced effects on mood symptoms (Profile of Mood States).
Time frame: 14-day follow-up phase after acute infusion visit.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 122 non-industry phase 2 interventional studies under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 24 months is below that.
Counting every sponsor, half of 134 studies reached it within 33 months; a quarter within 21 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Endotoxins
University of California, Los Angeles →