Adaptive Interventions for Opioid Use Disorder

(ADAPT-ED Trial)

Overseen By P'trice Jones, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: RAND

Must be taking: Buprenorphine

No Placebo Group

Trial Summary

What is the purpose of this trial?

The ADAPT-ED study is a two-stage, sequential multiple assignment randomized trial (SMART) to inform the development of an adaptive intervention that is optimally effective in increasing long-term buprenorphine use for adults presenting to the ED with probable opioid use disorder (OUD).

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the treatment ED-ITT, ED-ITT + BHS, SUN, SUN + Telebridge for opioid use disorder?

Research suggests that adding computer-based cognitive-behavioral therapy (CBT) and recovery coaching to buprenorphine treatment can help reduce substance use and improve recovery outcomes for people with opioid use disorder. Additionally, telephonic patient support has been shown to improve compliance and treatment outcomes in opioid dependence. ^{1 2 3 4 5}

Is the treatment for opioid use disorder safe for humans?

The safety of digital therapeutics for opioid use disorder has been evaluated in clinical trials, and these treatments have been authorized by the U.S. Food and Drug Administration (FDA) for use, indicating they are generally considered safe for humans. ^{6 7 8 9 10}

How is the treatment ED-ITT, ED-ITT + BHS, SUN, SUN + Telebridge unique for opioid use disorder?

This treatment is unique because it combines different adaptive interventions, including emergency department-initiated treatment (ED-ITT) and behavioral health support (BHS), with technology-enhanced options like SUN and Telebridge, aiming to personalize and improve engagement in opioid use disorder care. ^{1 3 11 12 13}

Eligibility Criteria

This trial is for English or Spanish-speaking adults over 18 who come to the ED with probable opioid use disorder (OUD) and can consent to participate. They must sign a consent form. People are excluded if they don't meet these criteria.

Inclusion Criteria

Presented for ED care at ARMC

Probable OUD diagnosis

Provide a signed and dated informed consent form

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

First Stage Treatment

Participants receive SUN-assisted treatment initiation and linkage to care, with or without immediate telehealth connection to an outpatient provider

Up to 90 days

Initial visit with potential follow-ups based on response

Second Stage Treatment

Non-responders receive ongoing buprenorphine treatment by an ED-based interim treatment team, with or without behavioral health support

Up to 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• ED-ITT (Behavioral Intervention)
• ED-ITT + BHS (Behavioral Intervention)
• SUN (Behavioral Intervention)
• SUN + Telebridge (Behavioral Intervention)

Trial Overview The ADAPT-ED study tests different combinations of interventions like SUN + Telebridge, ED-ITT, SUN alone, and ED-ITT + BHS in a two-stage process to see which helps increase long-term buprenorphine use in patients with OUD.

Participant Groups

Group I: SUN followed by ED-ITT Active Control 2 Interventions

In Arm B, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team.

Group II: SUN followed by ED-ITT + BHS Active Control 2 Interventions

In Arm C, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT + BHS condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team augmented with a behavioral health consultant who will provide behavioral health support for up to 3 months.

Group III: SUN + Telebridge followed by ED-ITT Active Control 2 Interventions

In Arm E, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team.

Group IV: SUN + Telebridge followed by ED-ITT + BHS Active Control 2 Interventions

In Arm F, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT + BHS condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team augmented with a behavioral health consultant who will provide behavioral health support for up to 3 months.

Group V: SUN with no follow up Active Control 1 Intervention

In Arm A, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be responders by 90 days and therefore receive no active follow up.

Group VI: SUN + Telebridge with no follow up Active Control 1 Intervention

In Arm D, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be responders by 90 days and therefore receive no active follow up.

Who Is Running the Clinical Trial?

RAND

Lead Sponsor

Trials

145

Recruited

617,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Arrowhead Regional Medical Center

Collaborator

Trials

18

Recruited

28,200+

Alameda Health System

Collaborator

Trials

9

Recruited

4,100+

Findings from Research

The study involved interviews with 14 individuals undergoing intensive outpatient treatment (IOT) for opioid use disorder (OUD), revealing that the process of connecting and disconnecting is crucial to their recovery experience.

Participants emphasized the importance of building connections with the IOT program, fellow patients, and staff, suggesting that fostering these relationships can significantly enhance engagement and support successful recovery from OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. Keen, A., Lu, Y., Draucker, CB.[2022]

The OVERCOME study is a randomized clinical trial designed to evaluate the effectiveness of combining computer-based cognitive-behavioral therapy (CBT4CBT) with Recovery Coaching for individuals with opioid use disorder (OUD) who are receiving buprenorphine treatment.

This integrated intervention aims to reduce substance use and improve adherence to buprenorphine, potentially lowering the risk of mortality associated with OUD, as indicated by the study's focus on drug positivity rates and retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale, design, and methodology of a randomized pilot trial of an integrated intervention combining computerized behavioral therapy and recovery coaching for people with opioid use disorder: The OVERCOME study. Pericot-Valverde, I., Perez, A., Heo, M., et al.[2022]

The Smart Prescription Management (SPM) intervention significantly reduced opioid prescriptions from an average of 18 to 1.8 per patient, leading to a 30-90% improvement in managing doctor shopping and reducing overdose events and mortality.

The Smart Consumption Monitoring (SCM) intervention improved opioid adherence and decreased the likelihood of addiction by 10-30%, highlighting the effectiveness of adaptive interventions in preventing opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive interventions for opioid prescription management and consumption monitoring. Singh, N., Varshney, U.[2023]

Patient activation, which involves actively participating in treatment decisions and taking responsibility for recovery, is crucial for positive outcomes in individuals with opioid use disorder (OUD) in intensive outpatient treatment (IOT) programs, as identified through interviews with 14 participants.

The study identified six key types of patient activation behaviors, highlighting the importance of collaboration with staff and self-determination in recovery, suggesting that IOT programs should foster these active roles while being cautious about the timing of certain interventions to avoid hindering recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Activation of Persons With Opioid Use Disorder in Intensive Outpatient Treatment. Keen, A., Lu, Y., Oruche, UM., et al.[2022]

A telephonic patient support program, HereToHelp™ (HTH), significantly improved compliance among opioid-dependent patients new to buprenorphine treatment, with 64.4% of participants compliant compared to 56.1% in the standard care group after 12 months.

Patients who were compliant with buprenorphine and engaged with the HTH program reported lower severity of addiction-related problems, indicating that the program not only enhanced compliance but also led to better overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of telephonic patient support on treatment for opioid dependence: outcomes at one year follow-up. Ruetsch, C., Tkacz, J., McPherson, TL., et al.[2013]

In a study of 3144 patients with opioid use disorder, the prescription digital therapeutic (PDT) reSET-O showed high engagement, with 80% of patients completing at least 8 out of 67 therapeutic modules, which is linked to improved treatment outcomes.

Patients who engaged with reSET-O demonstrated significant abstinence rates, with 66% abstinent in the last 4 weeks of treatment and 91% meeting the responder definition, indicating that this digital tool can effectively support traditional buprenorphine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. Maricich, YA., Xiong, X., Gerwien, R., et al.[2021]

A study involving 204 emergency patients showed that a 30-minute counseling session using motivational interviewing techniques significantly reduced risky opioid use behaviors compared to those who only received printed educational materials.

Patients who received the counseling intervention had a greater reduction in overdose risk behaviors after six months, indicating the efficacy of the intervention in addressing opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ED-based Counseling Sessions Reduce Risky Opioid Use Among Certain Patients. [2018]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

The HOPE mobile app was developed based on feedback from 16 interviews with patients and providers, incorporating features for mood tracking, treatment adherence, and community support, which were well-received by users.

In a 6-month pilot study with 25 patients, the app demonstrated high usability scores (mean 86.9 for patients and 83.3 for providers), indicating that it effectively supports individuals undergoing medication-assisted treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study. Waselewski, ME., Flickinger, TE., Canan, C., et al.[2021]

A significant increase in Opioid Use Disorder (OUD) diagnoses during pregnancy highlights the need for effective treatment solutions, which this study addresses through feedback from 18 peripartum individuals and 19 obstetric providers.

The development of the Listening to Women and Pregnant and Postpartum People (LTWP) program, informed by qualitative interviews, aims to enhance the implementation of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) in prenatal care, although initial feedback indicated a lack of enthusiasm for the web-based intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening to women and pregnant and postpartum people: Qualitative research to inform opioid use disorder treatment for pregnant and postpartum people. Guille, C., Hall, C., King, C., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Connecting and disconnecting: Experiences of people with opioid use disorder in intensive outpatient treatment. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Rationale, design, and methodology of a randomized pilot trial of an integrated intervention combining computerized behavioral therapy and recovery coaching for people with opioid use disorder: The OVERCOME study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Adaptive interventions for opioid prescription management and consumption monitoring. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Patient Activation of Persons With Opioid Use Disorder in Intensive Outpatient Treatment. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effect of telephonic patient support on treatment for opioid dependence: outcomes at one year follow-up. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Engagement in the Overdose RIsk InfOrmatioN (ORION) e-Health Tool for Opioid Overdose Prevention and Self-Efficacy: A Preliminary Study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

ED-based Counseling Sessions Reduce Risky Opioid Use Among Certain Patients. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of adjunctive, personalised psychosocial intervention for non-response to opioid agonist treatment: Study protocol for a pragmatic randomised controlled trial. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Listening to women and pregnant and postpartum people: Qualitative research to inform opioid use disorder treatment for pregnant and postpartum people. [2023]