Can the Gut Help Fight Addiction? A Clinical Study on Rifaximin and the Microbiota–Brain Connection
EU CTIS ID: 2025-524778-41-00
What this study is testing
The primary objective is to determine whether 4 weeks of treatment with rifaximin, compared with placebo, results in measurable improvement in intestinal barrier integrity and gut-derived inflammatory signalling compared with placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of OUD according to DSM‑5 criteria; patients in the early phase of withdrawal or in treatment with the intention to discontinue opioid use; age between 18 and 60 years; for female participants, not pregnant and not breastfeeding; ability to understand and sign informed consent. Patients with recent abstinence (e.g., within 1–4 weeks from last opioid use) will be preferentially included to capture the early adaptation phase, but not those in uncontrolled acute withdrawal. Patients receiving methadone maintenance treatment are eligible, provided they are on a stable dose and willing not to modify it for at least the first month of the study.
You likely can't join if
- Presence of known organic gastrointestinal diseases (e.g., Crohn’s disease, ulcerative colitis, untreated celiac disease, advanced-stage liver cirrhosis, GI malignancies) that may significantly alter intestinal permeability or contraindicate biopsy; diagnosis of active chronic infection; severe uncontrolled medical conditions; active psychiatric disorders that impair cooperation; current use of antibiotics or probiotics that significantly alter the microbiota (requiring at least a 4‑week washout before the study); HIV/AIDS or immunocompromised status; known allergy or severe adverse reaction to rifaximin or to antibiotics of the rifamycin class; for women, confirmed or planned pregnancy during the study period. Concurrent participation in other interventional clinical trials; inability to comply with study procedures.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.