Opioid Use DisorderPhase 2NCT07011758
Dynamic Treatment Regimes for Opioid Use Disorder
A Phase 2 study testing Medication for opioid use disorder and psychotherapy in people with Opioid Use Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Medication for opioid use disorder and psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2028to 1 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Diagnosed with opioid use disorder (OUD)
- Receiving care at a participating Discovery Behavioral Health site
- Able to provide informed consent
Who cannot join
- Significant cognitive impairment or psychiatric instability that would prevent participation
- Current incarceration or involuntary commitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Discovery Behavioral Health
Irvine, California, 92612
Rachel Wood, PhD, 415-828-5190, rwood@discoverybh.com
About this study
Official title: Dynamic Treatment Regimes for Personalized Opioid Use Disorder Care
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.
Read the 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, 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Medication for opioid use disorder, psychotherapy
- Keywords
- opioid use disorder
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication for opioid use disorderDrug
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.
psychotherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Retention in treatment
Whether participants remained engaged in behavioral health treatment through the end of the 4-week study period.
Measured: 4 weeks
Patient and clinician satisfaction
Participant- and provider-reported satisfaction with the trial experience and procedures, assessed via standardized surveys.
Measured: 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.
Measured: 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.
Measured: Throughout the 4-week trial
Timeliness of EHR data entry
Proportion of EHR entries recorded within 48 hours of patient interaction.
Measured: Weekly throughout the 4-week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jul 2028 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jason Brian Gibbons, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011758
- Sponsor's protocol ID
- 2025p001360
- Other IDs
- K01DA061975
- Status last verified
- Nov 2025
- First submitted
- 2 Jun 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during the study, including survey responses, CAT-SUD scores, and treatment assignments, will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Treatment Regimes for Personalized Opioid Use Disorder Care
- ClinicalTrials.gov ID
- NCT07011758
- Acronym / sponsor ID
- 2025p001360
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2028 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Initial Intervention A + B | Experimental | Drug: Medication for opioid use disorder, Behavioral: psychotherapyParticipants 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. |
| Initial Intervention A + D | Experimental | Drug: Medication for opioid use disorder, Behavioral: psychotherapyParticipants 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. |
| Initial Intervention C + B | Experimental | Behavioral: psychotherapyParticipants 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. |
| Initial Intervention C + D | Experimental | Behavioral: psychotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Diagnosed with opioid use disorder (OUD)
- Receiving care at a participating Discovery Behavioral Health site
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Significant cognitive impairment or psychiatric instability that would prevent participation
- Current incarceration or involuntary commitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication for opioid use disorderA 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. | Drug | Initial Intervention A + B, Initial Intervention A + D |
| psychotherapyA 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. | Behavioural | Initial Intervention A + B, Initial Intervention A + D, Initial Intervention C + B, Initial Intervention C + D |
Primary outcome
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.
Retention in treatment
Time frame: 4 weeks
Whether participants remained engaged in behavioral health treatment through the end of the 4-week study period.
Patient and clinician satisfaction
Time frame: 4 weeks
Participant- and provider-reported satisfaction with the trial experience and procedures, assessed via standardized surveys.
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.
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.
Timeliness of EHR data entry
Time frame: Weekly throughout the 4-week trial
Proportion of EHR entries recorded within 48 hours of patient interaction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during the study, including survey responses, CAT-SUD scores, and treatment assignments, will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medication for opioid use disorder and psychotherapy in people with Opioid Use Disorder, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason B Gibbons, PhD (7734011266, jbgibbons@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAT-SUD severity scores (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.