Alcohol Use DisorderPhase 2NCT07452146
Endotoxin Exposure to Examine the Role of Inflammation in Alcohol Use
A Phase 2 study testing Endotoxin in people with Alcohol Use Disorder and Inflammatory Response, run by University of California, Los Angeles.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Inflammatory Response, Craving
- What is being tested?
- Endotoxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between the ages of 21 and 65
- Meet current (i.e., past month) DSM-5 diagnostic criteria for moderate to severe AUD
- Alcohol use disorder identification test (AUDIT) score <20
- Be non-treatment seeking for AUD
- 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.
- Must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:
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- 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
- Be between the ages of 21 and 65
- No lifetime history (i.e., past year) DSM-5 diagnostic criteria for AUD
- Alcohol use disorder identification test (AUDIT) score <8
- 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.
- 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
Who cannot join
- 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, major depressive 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 onvthe 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)
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- 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
- Have a body mass index (BMI) greater than 30
- 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
- To participate in the inflammatory challenge, participants must not show any of the following upon arrival to the inflammatory challenge study visit:
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Understanding the Role of Inflammation in Alcohol Use Disorder: An Inflammatory Challenge Using Lipopolysaccharide
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.
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder, Inflammatory Response, Craving
- Being tested
- Endotoxin, Placebo saline
- Keywords
- Endotoxin
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndotoxinDrug
Also called Lipopolysaccharide
Bolus dose of 0.8 ng/kg
Placebo salineOther
Matched to endotoxin
| Study group | Role | What they receive |
|---|---|---|
| Endotoxin | Experimental | Individuals with alcohol use disorder vs. control who receive a bolus dose of endotoxin (0.8 ng/kg of body weight). Receives: Drug: Endotoxin |
| Placebo | Placebo comparator | Individuals with alcohol use disorder vs. control matched to endotoxin at same volume of 0.9% saline solution. Receives: Other: Placebo saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 14-day follow-up phase after acute infusion visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, triple-blind, placebo-controlled, parallel-group study of low dose endotoxin (0.8 ng/kg)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lara Ray, PhD, University of California, Los Angeles
- Investigators
- Lara Ray, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452146
- Sponsor's protocol ID
- 25-1738
- Other IDs
- 2K24AA025704-06
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Inflammation in Alcohol Use Disorder: An Inflammatory Challenge Using Lipopolysaccharide
- ClinicalTrials.gov ID
- NCT07452146
- Acronym / sponsor ID
- 25-1738
- Conditions
- Alcohol Use Disorder, Inflammatory Response, Craving
- Keywords
- Endotoxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, triple-blind, placebo-controlled, parallel-group study of low dose endotoxin (0.8 ng/kg)
| Arm | Type | Receives |
|---|---|---|
| Endotoxin | Experimental | Drug: EndotoxinIndividuals with alcohol use disorder vs. control who receive a bolus dose of endotoxin (0.8 ng/kg of body weight). |
| Placebo | Placebo comparator | Other: Placebo salineIndividuals with alcohol use disorder vs. control matched to endotoxin at same volume of 0.9% saline solution. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Be between the ages of 21 and 65
- Meet current (i.e., past month) DSM-5 diagnostic criteria for moderate to severe AUD
- Alcohol use disorder identification test (AUDIT) score <20
- Be non-treatment seeking for AUD
- 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.
Key exclusion criteria (21 listed)
- 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, major depressive 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 onvthe Columbia-Suicide Severity Rating Scale (C-SSRS)
- Have a positive urine screen for drugs other than cannabis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndotoxinAlso: LipopolysaccharideBolus dose of 0.8 ng/kg | Drug | Endotoxin |
| Placebo salineMatched to endotoxin | Other | Placebo |
Primary outcome
Acute Phase: To determine the effect of acute inflammation on mood in AUD versus controls.
Time frame: Mood will be collected at baseline (prior to infusion) and hourly for 4 hours post-infusion.
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.
Acute Phase: To determine the effect of acute inflammation on cue-reactivity in AUD versus controls.
Time frame: The cue-reactivity paradigm is conducted at baseline and at 2 hours post-infusion during the experimental visit.
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.
Acute Phase: To determine the effect of acute inflammation on biomarkers in AUD versus controls.
Time frame: Blood samples will be collected at baseline (prior to infusion) and hourly for 4 hours post-infusion.
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.
Follow-up Phase: To determine the protracted effects of acute inflammation on self-reported craving and alcohol use in AUD versus controls.
Time frame: 14-day follow-up phase after acute infusion visit.
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.
Follow-up Phase: To determine the protracted effects of acute inflammation on mood in AUD versus controls.
Time frame: 14-day follow-up phase after acute infusion visit.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lara Ray, PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endotoxin in people with Alcohol Use Disorder and Inflammatory Response, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lara Ray, PhD ((310) 794-5383, lararay@psych.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Phase: To determine the effect of acute inflammation on mood in AUD versus controls. (time frame: Mood will be collected at baseline (prior to infusion) and hourly for 4 hours post-infusion.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.