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Metformin for Immune Health in Individuals with History of Injection Drug Use

This study is looking at whether Metformin, a common diabetes medication, can help reduce body-wide inflammation (systemic inflammation) and improve the immune system in people who have a history of injection drug use, whether or not they also have HIV. You would receive either Metformin ER (starting at 500mg and increasing to 1000mg) or a placebo (an inactive pill) for 16 weeks. All participants will also receive two vaccines, Jynneos (for Mpox) and Capvaxvie (for pneumococcal disease). The main goal is to see if Metformin changes a marker of inflammation called C-reactive protein (CRP) in your blood over 16 weeks. The study aims to enroll 100 adults between 18 and 64 years old.

Study design
This is a randomized clinical trial, meaning participants are randomly assigned to receive either Metformin or a placebo. It plans to enroll 100 participants.
What's involved
You would take either Metformin or a placebo for 16 weeks and receive two vaccines. Your immune responses will be checked for 6 months after you join the study.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for 6 months after enrollment to assess immune responses.

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NCT06829238

Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use

Recruiting
PHASE4Ages 18–64InterventionalTreatment
University of Alabama at Birmingham
~100 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:MetforminPlaceboJynneosCapvaxvie

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Serum C-reactive Protein (CRP)
Measured over Baseline to Week 16

Conditions

Systemic Inflammation
Immune Dysregulation
Injection Drug Use
HIV

Explore related trials

HIV InfectionImmune dysregulationInjection drug useSystemic autoinflammationCD4 GeneCRP GeneGlucoseHemoglobin A1C MeasurementHIV Infection

Where it's being run

1 sites across 1 states
Alabama1

Who to contact

Ellen Eaton, MD, MSPH
[email protected]
205-975-0661
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent.
Stated willingness to comply with all study procedures and availability for the study duration.
Aged 18 to 64 years old.
Weight of at least 110 lbs.
Body Mass Index (BMI) of 18.5-40. Enrollment of individuals with BMI \>40, deemed in good health, may be considered with approval.
Willingness to receive Jynneos (MPOX) and Capvaxvie vaccines.
Ability to take oral medication and willingness to adhere to the metformin treatment regimen.
History of injection opioid, amphetamine, and/or cocaine use within the past 10 years (self-report).
Use of non-prescription opioid, amphetamine, and/or cocaine within the past 30 days (self-report).
Clinically confirmed urine drug screen for opioid, amphetamine, and/or cocaine within the past 30 days.
Serum CRP \> 3 mg/dL.
Glucose level between 70-180 mg/dL (non-fasting).
Hemoglobin A1c (HbA1c) of 5.0-6.4%.
CD4 count \> 200 cells/ml.
If HIV-positive, HIV viral load \< 200 copies/ml.
If HIV-positive, on anti-retroviral therapy (ART) for \>12 months.

Exclusion

Inability to give informed consent.
Refusal or inability to have blood drawn.
Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, platelet disorder requiring precautions).
Pregnant or nursing individuals.
Diabetes mellitus.
History of severe renal impairment or eGFR \<60 mL/min/1.73m².
Creatinine clearance \<60 mL/min.
History of liver disease.
ALT/AST \> 3× the upper limit of normal.
Total bilirubin \>1.4 mg/dL.
Albumin \<3.5 g/dL.
Prothrombin \>1.5× the upper limit of normal.
AUDIT-C score ≥8.
Hemoglobin \<9.0 g/L.
Absolute neutrophil count \<1,000/mL.
Platelet count \<100,000/mL.
History of acute or chronic metabolic acidosis.
Serum bicarbonate \<22 mEq/L.
Anion gap \>10 mEq/L.
Serum lactate \>2.2 mmol/L.
Serum vitamin B12 \<250 pg/mL.
History of chronic diarrhea.
Current use of metformin or other diabetes medications.
History of myocardial infarction, endocarditis, stroke, heart failure, chronic obstructive pulmonary disease, or sepsis.
Use of medications such as furosemide, nifedipine, ranolazine, vandetanib, or cimetidine (current or within the past 30 days).
Active hepatitis B infection.
Hepatitis C infection within 6 months of study entry; individuals with prior hepatitis C must be at least 6 months post-treatment with direct-acting antivirals.
Previous receipt of Jynneos or pneumococcal vaccine within the past two years (self-report).
Severe allergic reaction to metformin, Jynneos, or Capvaxvie (self-report). Blood donations exceeding 450 mL in the 8 weeks prior to enrollment, accounting for study-related blood draws.
Any medical, psychiatric, social condition, or responsibility that, in the investigator's judgment, could interfere with study procedures.

What this trial measures

  • Change in Serum C-reactive Protein (CRP)Baseline to Week 16

    Assessed by Enzyme Linked Immunosorbent Assay (ELISA) of blood samples collected at baseline and at 16 weeks. Reported in mg/dL.