Medication and Psychotherapy for Opioid Use Disorder

Overseen By Jason B Gibbons, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Disqualifiers: Cognitive impairment, Psychiatric instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to treat opioid use disorder (OUD) by combining medications and therapy. Researchers aim to identify the best treatment plans to reduce overdose risk and improve recovery outcomes. Participants will receive various treatment combinations each week, adjusted according to their progress. The trial seeks individuals diagnosed with OUD who are already receiving care at a participating Discovery Behavioral Health site. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dynamic treatment regimes (DTRs) aim to improve personalized care for people with opioid use disorder (OUD). These treatments adapt over time based on individual progress. The goal is to find the best treatment path to reduce overdose risk and support recovery.

Early findings suggest that DTRs focus on achieving optimal results while managing risks. Treatments are adjusted to minimize negative side effects. Although clear data on treatment tolerance is not yet available, studies remain in the early stages, and researchers continue to collect detailed safety information.

As this research is in an early phase, not all risks are known. However, the treatment's adaptability and potential to enhance safety over time are promising. Participants should discuss any concerns with the study team to understand expectations and possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for opioid use disorder because they use dynamic treatment regimes that adapt based on individual responses. Unlike standard treatments, which often involve a fixed combination of medications like methadone, buprenorphine, or naltrexone paired with traditional counseling, these new approaches tailor interventions weekly. By leveraging predictive models and adaptive algorithms, they aim to optimize therapy for each participant, potentially improving outcomes more rapidly and effectively. This personalized approach could represent a significant advancement in treating opioid use disorder, offering hope for more precise and responsive care.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that personalized treatment plans hold promise for treating opioid use disorder (OUD). Studies have found that tailoring treatment to individual needs can lead to better results. This trial will explore various combinations of interventions, such as Intervention A with Intervention B, and Intervention C with Intervention D, among others. For instance, medications like buprenorphine and methadone effectively reduce relapse. Buprenorphine can lower the risk of overdose when used correctly, while methadone often helps people remain in treatment longer. By customizing these treatments to fit each person's progress and response, personalized approaches may offer even better outcomes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with opioid use disorder who are seeking personalized treatment options. The study will develop and test tailored treatment sequences to reduce overdose risk and enhance recovery.

Inclusion Criteria

Able to provide informed consent

Diagnosed with opioid use disorder (OUD)

Receiving care at a participating Discovery Behavioral Health site

Exclusion Criteria

I do not have any mental health issues that would stop me from participating.

Current incarceration or involuntary commitment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Modeling and Estimation

Multiple machine learning approaches are used to estimate and validate dynamic treatment regimes (DTRs) based on patient characteristics and treatment response.

Not specified

Pilot Hybrid Factorial SMART Trial

Conduct a pilot trial to test the feasibility and acceptability of implementing the highest-performing DTR in a clinical setting. This includes recruitment, retention, adherence to treatment paths, and integration into routine care.

4 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic Treatment Regimes

Trial Overview The study is testing dynamic treatment regimes that combine medication for opioid use disorder with psychotherapy, using machine learning to optimize the sequence of treatments based on individual patient data.

How Is the Trial Designed?

Group I: Initial Intervention C + D Experimental Treatment 1 Intervention

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.

Group II: Initial Intervention C + B Experimental Treatment 1 Intervention

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.

Group III: Initial Intervention A + D Experimental Treatment 2 Interventions

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.

Group IV: Initial Intervention A + B Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11637529/

Learning optimal dynamic treatment regimes from ... The goal of this paper is to provide a tutorial for estimating ODTR from longitudinal observational and clinical trial data for applied researchers.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07011758?lastUpdPost=2020-03-16_

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).

3. arxiv.org arxiv.org/html/2401.10867v1

Learning Optimal Dynamic Treatment Regimes from ... Buprenorphine & methadone dosing strategies to reduce risk of relapse in the treatment of opioid use disorder. Drug and alcohol dependence ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624000334

Estimated effectiveness and cost-effectiveness of opioid ... Buprenorphine and methadone OUD treatment under NPRM are likely to be effective and cost-effective. Increases in overdose risk with take-home methadone would ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/6/e095645

Effectiveness of methadone versus buprenorphine in the ... The data comparing the effectiveness of MMT to bup/nal for OUD are mixed, however. While many studies have identified that MMT is superior for retention in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12448091/

Thresholds for adjunctive medication usage and probability ... A dynamic treatment regime is a sequence of a priori-specified treatment decisions that may depend on patient baseline and time-varying ...

7. researchgate.net researchgate.net/publication/381467788_Learning_Optimal_Dynamic_Treatment_Regimes_from_Longitudinal_Data

Learning Optimal Dynamic Treatment Regimes from ... Treatment outcomes were opioid use during the final 30 days of treatment (among treatment completers) and treatment attrition. Results: Non-opioid substance ...

8. tandfonline.com tandfonline.com/doi/abs/10.1080/01621459.2023.2270637

Controlling Cumulative Adverse Risk in Learning Optimal ... We propose a general statistical learning framework to learn optimal DTRs that maximize the reward outcome while controlling the cumulative adverse risk.

9. medicine.yale.edu medicine.yale.edu/internal-medicine/genmed/addictionmedicine/research/current-studies/

Current Studies < Yale Program in Addiction Medicine The study additionally explores social, structural, and environmental influences on treatment outcomes for existing and emerging opioid agonist treatment ...