Dynamic Treatment Regimes for Opioid Use Disorder

NCT07011758 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025p001360K01DA061975
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Opioid Use Disorder

Keywords

opioid use disorder

Outcome Measures

Primary Outcomes (6)

• CAT-SUD severity scores

  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.

  4 weeks

• Retention in treatment

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

  4 weeks

• Patient and clinician satisfaction

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

  4 weeks

• Clinical fidelity to intervention protoco

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

  Weekly over 4-week study period

• Data completeness and consistency

  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.

  Throughout the 4-week trial

• Timeliness of EHR data entry

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

  Weekly throughout the 4-week trial

Study Arms (4)

Initial Intervention A + B

EXPERIMENTAL

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.

Drug: Medication for opioid use disorder; Behavioral: psychotherapy

Initial Intervention A + D

EXPERIMENTAL

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.

Drug: Medication for opioid use disorder; Behavioral: psychotherapy

Initial Intervention C + B

EXPERIMENTAL

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.

Behavioral: psychotherapy

Initial Intervention C + D

EXPERIMENTAL

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.

Behavioral: psychotherapy

Interventions

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.

Initial Intervention A + B; Initial Intervention A + D

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.

Initial Intervention A + B; Initial Intervention A + D; Initial Intervention C + B; Initial Intervention C + D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Discovery Behavioral Health

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Dosage Forms; Psychotherapy

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Behavioral Disciplines and Activities

Central Study Contacts

Jason B Gibbons, PhD

CONTACT

7734011266; jbgibbons@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial; no participants, providers, or investigators are masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design. Participants are initially randomized in a 2x2 factorial structure in Week 1 to receive one of four treatment combinations. In Weeks 2-4, additional weekly treatment components are assigned based on participant response and predefined decision rules. This structure allows for evaluation of dynamic treatment regimens tailored to individual needs and evolving treatment response.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start (Estimated): July 1, 2028
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 1 year after study completion.
• Access Criteria: equests will be reviewed by the principal investigator. Data will be shared through a secure data use agreement upon IRB approval and execution of a data-sharing agreement.

Locations

US (1)