Could a common diabetes drug tame inflammation in drug users?
NCT ID NCT06829238
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether metformin, a common diabetes drug, can reduce harmful inflammation and improve immune function in 100 adults aged 18-64 who have a history of injection drug use, some of whom also have HIV. Participants take metformin or a placebo for 16 weeks and receive two vaccines to see how their immune systems respond. The goal is to find a safe way to restore immune balance in this high-risk group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin
- What this could lead to
- If it works, this could point toward a way to reduce chronic inflammation and improve vaccine responses in people with a history of injection drug use.
- What could go wrong
- This is a small, early-phase trial with only 100 participants, so results may not apply broadly. Metformin is generally safe but can cause gastrointestinal side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Nov 2029
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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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * 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 Criteria: * 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.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35294, United States
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