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Dynamic Treatment Regimes for Opioid Use Disorder

NCT07011758 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-11-04

No results posted yet for this study

Summary

This study aims to develop and evaluate dynamic treatment regimes (DTRs) to improve personalized care for individuals with opioid use disorder (OUD). Using machine learning methods and longitudinal data from a national behavioral health provider, the investigators will identify optimal treatment sequences that minimize the risk of overdose and improve recovery outcomes. A pilot hybrid factorial SMART trial will be conducted to assess the feasibility and acceptability of implementing these personalized treatment decision rules in real-world clinical settings.

Conditions

Interventions

DRUG

Medication for opioid use disorder

A medication treatment component delivered in Week 1 as part of a 2×2 factorial SMART design. The exact content (e.g., treatment modality or intensity) will be finalized based on model results from Aim 1, which identifies optimal dynamic treatment regimes.

BEHAVIORAL

psychotherapy

A behavioral treatment component delivered in Week 1 as part of a 2×2 factorial SMART design. The exact content (e.g., treatment modality or intensity) will be finalized based on model results from Aim 1, which identifies optimal dynamic treatment regimes.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-07-01
Primary Completion
2029-06-01
Completion
2030-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07011758 on ClinicalTrials.gov