Adaptive Interventions for Opioid Use Disorder

(ADAPT-ED Trial)

Overseen By P'trice Jones, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RAND

Must be taking: Buprenorphine

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve the long-term use of buprenorphine, a medication for opioid use disorder (OUD), among adults visiting the emergency department. Researchers aim to determine the most effective methods to help individuals with probable OUD continue their treatment, utilizing support methods like telehealth and behavioral health support. The trial is ideal for those diagnosed with probable OUD who have sought care in the emergency department. Participants will be assigned to different groups, such as ED-ITT (emergency department-initiated treatment and transition) and SUN (Substance Use Navigation), to evaluate which support method best facilitates ongoing treatment success. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies for enhancing OUD treatment.

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.

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

Research shows that the treatments in this trial for opioid use disorder (OUD) vary in safety and effectiveness.

For the ED-ITT (Emergency Department-Interim Treatment Team), past studies highlight its role in initiating OUD treatment in emergency settings. These programs quickly connect people to care and have successfully done so. Safety reports indicate that patients generally tolerate the treatments well, with manageable side effects.

Adding a behavioral health specialist (BHS) to the ED-ITT team provides extra support. This combination has been studied, and while it can improve patient outcomes, safety remains similar to ED-ITT alone. Reports suggest that most patients do not experience serious side effects.

The SUN (Substance Use Navigation) approach guides patients through treatment steps. Studies have found that it reduces overdoses and connects patients to ongoing care. It is considered safe, with no major safety concerns reported.

Using SUN with Telebridge, which includes telehealth connections, has gained popularity, especially during the pandemic. This method has been shown to be safe and well-received by patients, helping keep them engaged in treatment through remote support.

Overall, these treatments have strong safety records. While individual experiences may vary, the treatments are generally well-tolerated and effective in managing OUD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these adaptive interventions for opioid use disorder because they offer a personalized approach to treatment. Unlike traditional methods that often rely solely on medication like methadone or buprenorphine, these interventions integrate behavioral health support and telehealth connections to tailor care based on individual responses. The SUN-assisted treatments help initiate care and link patients to necessary resources quickly, while the addition of telehealth and behavioral health services supports ongoing recovery. This approach has the potential to be more effective by addressing both the medical and psychological aspects of addiction, potentially leading to better long-term outcomes.

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

Research shows that starting buprenorphine treatment in emergency departments (ED) can effectively help people with opioid use disorder (OUD) begin their recovery. In this trial, participants may receive the ED-ITT program, which studies have found can increase the chances of patients beginning and continuing OUD treatment. Another arm of this trial includes ED-ITT + BHS, where adding behavioral health support (BHS) further improves treatment success by offering ongoing counseling. Participants may also be part of the SUN (Substance Use Navigation) program, which connects patients to care and has been linked to doubling the rate of starting medication for OUD compared to those without it. Additionally, the SUN + Telebridge approach, another arm in this trial, combines SUN with telehealth services, making it easier for patients to stay involved in their recovery by benefiting from convenience and quick access to care. These interventions in the trial aim to make it easier for patients to continue their treatment journey outside the ED, focusing on long-term recovery success. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ED-ITT
• ED-ITT + BHS
• SUN
• SUN + Telebridge

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

A personalized psychosocial intervention (PSI) is being tested in a clinical trial with 368 adults over 18 weeks to see if it can improve outcomes for patients with opioid use disorder who are not responding well to standard opioid agonist therapy (OAT).

The primary goal of the trial is to measure the effectiveness of PSI in achieving self-reported abstinence from heroin and cocaine, which will help tailor future treatments for individuals struggling with OUD.

NCBI (Pubmed)

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. Marsden, J., Stillwell, G., Hellier, J., et al.[2022]

The ORION tool, an innovative e-health psychoeducational software, was developed to inform opioid-dependent individuals about overdose risks and identified seven key risk factors related to their behaviors.

While the ORION tool did not significantly change self-efficacy scores in participants, it effectively identified those at higher risk, suggesting that it could be a valuable component of a broader intervention strategy when combined with other support methods.

NCBI (Pubmed)

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. Carrà, G., Crocamo, C., Humphris, G., et al.[2022]

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 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]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8380665/

Emergency department–based efforts to offer medication ... This study's objective is to identify features of ED-based OUD treatment programs that relate to program implementation, effectiveness, and sustainability.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788378

Perspectives About Emergency Department Care ... This qualitative study assesses the experiences and perspectives of individuals with untreated opioid use disorder seen in emergency ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0196064423001026

Qualitative Exploration of Emergency Department Care ... We described the experiences and preferences of people with opioid use disorder who access emergency department (ED) services regarding ED care and ED-based ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7994945/

Objective outcome measures in randomized clinical trials ... Objective outcome assessments in emergency department (ED)-based clinical trials for OUDs address issues of loss to follow-up (LTFU) and reporting bias.

5. jem-journal.com jem-journal.com/article/S0736-4679(20)30016-0/abstract

Management of Opioid Use Disorder in the Emergency ... Emergency department treatment of opioid addiction ... treatment of opioid dependence during pregnancy-initial patient care and outcome data.

6. annemergmed.com annemergmed.com/article/S0196-0644(20)30511-4/fulltext

Clinical Policy: Critical Issues Related to Opioids in Adult ... Emergency physicians are on the front lines, regularly treating opioid overdoses and other adverse effects such as injection-drug-related complications, OUD, ...

7. aspe.hhs.gov aspe.hhs.gov/reports/ed-interventions-oud

Emergency Department Interventions for Opioid Use Disorder ASPE conducted this study to identify innovative models and key characteristics of ED programs that initiate or facilitate engagement in OUD treatment.