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NCT Number: NCT07011758

Dynamic Treatment Regimes for Opioid Use Disorder

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medication for opioid use disorder

Drug

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.

Psychotherapy

Behavioral

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.

Primary outcomes

  1. CAT-SUD severity scores

    Time frame: 4 weeks

    Weekly Computerized Adaptive Test for Substance Use Disorder severity T-score. Scores range 0-100 (≈5-point precision). Higher scores indicate a greater SUD symptom burden/risk, while lower scores indicate fewer symptoms/lower risk. Prior validation studies have used <50 = low, 50-70 = intermediate, >70 = high severity/risk thresholds. Computerized Adaptive Test for Substance Use Disorder provides a dimensional severity score (not a diagnosis). Change is assessed week-to-week.

  2. Retention in treatment

    Time frame: 4 weeks

    Whether participants remained engaged in behavioral health treatment through the end of the 4-week study period.

  3. Patient and clinician satisfaction

    Time frame: 4 weeks

    Participant- and provider-reported satisfaction with the trial experience and procedures, assessed via standardized surveys.

  4. Clinical fidelity to intervention protoco

    Time frame: Weekly over 4-week study period

    Fidelity of intervention delivery assessed via clinician checklists or independent fidelity ratings, evaluating adherence to protocol for each assigned treatment component.

  5. Data completeness and consistency

    Time frame: Throughout the 4-week trial

    Proportion of participants for whom ethical standards are fully maintained (e.g., informed consent obtained, no reported violations).

    Proportion of participants for whom ethical standards are fully maintained (e.g., informed consent obtained, no reported violations).

    Proportion of EHR and survey data points with missing or inconsistent entries. Thresholds for success include <5% missingness or inconsistency.

  6. Timeliness of EHR data entry

    Time frame: Weekly throughout the 4-week trial

    Proportion of EHR entries recorded within 48 hours of patient interaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason B Gibbons, PhD

CONTACT

[email protected]

7734011266

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Dynamic Treatment Regimes for Personalized Opioid Use Disorder Care

Important dates

Study start
2028
Primary completion
2029
Study completion
2030
First posted
Jun 10, 2025
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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