Dynamic Treatment Regimes for Opioid Use Disorder

Mass General Brigham

Status and phase: Begins enrollment in a year or more; Phase 2

Conditions: Opioid Use Disorder

Treatments: Drug: Medication for opioid use disorder; Behavioral: psychotherapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07011758

2025p001360

K01DA061975 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

This project supports the development and testing of dynamic treatment regimes (DTRs) for individuals with opioid use disorder (OUD), leveraging clinical and behavioral data from Discovery Behavioral Health and linked administrative records. In the first phase, multiple machine learning approaches (e.g., Q-learning, causal forests) will be used to estimate and validate DTRs that recommend tailored sequences of care based on patient characteristics and treatment response. The DTRs will be evaluated based on their ability to reduce fatal and non-fatal opioid overdose risk and hospital-based service use.

In the second phase, the investigators will conduct a pilot hybrid factorial Sequential Multiple Assignment Randomized Trial (SMART) to test the feasibility and acceptability of implementing the highest-performing DTR in a clinical setting. This pilot study will assess recruitment and retention, adherence to assigned treatment paths, and the practicality of integrating the DTR into routine care. The findings will inform a future full-scale trial aimed at improving personalized care for OUD and outcomes.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older
• Diagnosed with opioid use disorder (OUD)
• Receiving care at a participating Discovery Behavioral Health site
• Able to provide informed consent

Exclusion criteria

• Significant cognitive impairment or psychiatric instability that would prevent participation
• Current incarceration or involuntary commitment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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75 participants in 4 patient groups

Initial Intervention A + B

Experimental group

Description:

Participants randomized to receive the combination of Intervention A and Intervention B in Week 1. Additional weekly interventions in Weeks 2-4 will be assigned based on participant response and dynamic treatment algorithms derived in Aim 1.

Treatment:

Behavioral: psychotherapy

Drug: Medication for opioid use disorder

Initial Intervention A + D

Experimental group

Description:

Participants randomized to receive the combination of Intervention A and Intervention D in Week 1. Subsequent treatment assignments in Weeks 2-4 follow adaptive treatment decision rules.

Treatment:

Behavioral: psychotherapy

Drug: Medication for opioid use disorder

Initial Intervention C + B

Experimental group

Description:

Participants randomized to receive the combination of Intervention C and Intervention B in Week 1. Adaptive treatment components are added weekly based on observed outcomes and predictive models.

Treatment:

Behavioral: psychotherapy

Initial Intervention C + D

Experimental group

Description:

Participants randomized to receive the combination of Intervention C and Intervention D in Week 1. Participants receive additional interventions in Weeks 2-4 based on dynamic treatment regimes developed in the modeling phase.

Treatment:

Behavioral: psychotherapy