Clinical trial NCT07011758: Dynamic Treatment Regimes for Opioid Use Disorder
Official title: Dynamic Treatment Regimes for Personalized Opioid Use Disorder Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Opioid Use Disorder
Keywords: opioid use disorder
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-06-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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, we will identify optimal treatment sequences that minimize overdose risk 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.

Detailed 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, we 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. Findings will inform a future full-scale trial aimed at improving personalized OUD care and outcomes.

Eligibility criteria: 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

Primary outcomes:
measure: CAT-SUD severity scores
timeFrame: 4 weeks
measure: Retention in treatment
timeFrame: 4 weeks
measure: Patient and clinician satisfaction
timeFrame: 4 weeks
measure: Clinical fidelity to intervention protoco
timeFrame: Weekly over 4-week study period
measure: Data completeness and consistency
timeFrame: Throughout the 4-week trial
measure: Timeliness of EHR data entry
timeFrame: Weekly throughout the 4-week trial
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Discovery Behavioral Health
state: California
Study officials:
References: