substance use disorder
Conditions
Brief summary
The primary efficacy endpoints concern the improvement of craving and social disconnection/isolation in OUD paties treated with rifaximin compared with placebo. Specifically: Intensity of opioid craving, Indicators of social isolation/disconnection, Tapering of methadone therapy
Detailed description
Improvement in: Intestinal permeability measures, Fecal microbiota characteristics, Adverse events and infections
Interventions
DRUGNormix 200 mg compresse rivestite con film
DRUGThe placebo is a film-coated oral tablet designed to be comparable in appearance
DRUGadministration
DRUGand handling to the investigational medicinal product (rifaximin 200 mg film-coated tablets)
DRUGwhile containing no active pharmaceutical ingredient. The placebo consists exclusively of commonly used pharmaceutical excipients with established safety profiles and is administered solely to maintain blinding in the clinical trial.
Sponsors
Fondazione Santa Lucia
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoints concern the improvement of craving and social disconnection/isolation in OUD paties treated with rifaximin compared with placebo. Specifically: Intensity of opioid craving, Indicators of social isolation/disconnection, Tapering of methadone therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in: Intestinal permeability measures, Fecal microbiota characteristics, Adverse events and infections | — |
Outcome results
None listed