drugset / Trial / NCT06434818

Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders

NCT06434818 ↗

RandomizedParallel-groupSingle-blindTreatment

Summary

The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.

Timeline

Start
2023-07-07
Primary completion
2025-03-31
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance) Unknown 60 % —