NCT06829238

Brief Summary

This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
44mo left

Started Apr 2025

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Apr 2025Nov 2029

First Submitted

Initial submission to the registry

February 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

February 4, 2025

Last Update Submit

April 17, 2026

Conditions

Systemic InflammationImmune DysregulationInjection Drug UseHIV

Keywords

MetforminImmune restorationVaccine responsePeople who inject drugs (PWID)

Outcome Measures

Primary Outcomes (1)

  • Change in Serum C-reactive Protein (CRP)

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

    Baseline to Week 16

Secondary Outcomes (4)

  • Change in exhausted B cells

    Baseline to Week 16

  • Change in exhausted T cells

    Baseline to Week 16

  • Change in MPOX vaccine-specific IgG antibody.

    Baseline to Week 13

  • Change in PCV21 vaccine-specific IgG antibody.

    Baseline to Week 9

Study Arms (2)

Metformin Group

EXPERIMENTAL

Participants will receive Metformin ER (500mg increasing to 1000mg) for 16 weeks to assess immune restoration and inflammatory response.

Drug: MetforminBiological: JynneosBiological: Capvaxvie

Placebo Group

PLACEBO COMPARATOR

Control Group

Drug: PlaceboBiological: JynneosBiological: Capvaxvie

Interventions

MetforminDRUG

Participants will receive Metformin ER (500mg increasing to 1000mg) or placebo for 16 weeks to assess immune restoration and inflammatory response.

Metformin Group
PlaceboDRUG

Participants will receive placebo for 16 weeks and assess immune restoration and inflammatory response.

Placebo Group
JynneosBIOLOGICAL

All participants will take a Jynneos (MPOX) vaccine.

Metformin GroupPlacebo Group
CapvaxvieBIOLOGICAL

All participants will take a Capvaxvie (PCV21, pneumococcal) vaccine.

Metformin GroupPlacebo Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Interventions

Metforminsmallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Ellen Eaton, MD, MSPH

CONTACT

205-975-0661eeaton@uabmc.edu

James Kobie, PhD

CONTACT

205-934-8800jjkobie@uabmc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ellen Eaton

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 17, 2025

Study Start

April 7, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2029

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

US(1)