Dynamic Treatment Regimes for Opioid Use Disorder

Part of paid clinical trials in Irvine, California.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07011758
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2028
Status verified
Nov 2025
Primary completion
Jun 1, 2029
Completion
Jun 1, 2030

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Initial Intervention A + B
    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.
  • Experimental: Initial Intervention A + D
    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.
  • Experimental: Initial Intervention C + B
    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.
  • Experimental: Initial Intervention C + D
    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.

Primary Outcome Measure

CAT-SUD severity scores [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Discovery Behavioral HealthIrvineCalifornia92612
Rachel Wood, PhD
[email protected]
415-828-5190

Find similar trials in Irvine, CA

By research site
Discovery Behavioral Health· Irvine, CA

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