Buprenorphine Administration Support for Opioid Use Disorder

(ADAPT Trial)

Recruiting at 2 trial locations

Overseen By Laurel Buchanan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Opioid use disorder medications

Disqualifiers: Under 18, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

1912 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to simplify guideline adherence for emergency department doctors when administering buprenorphine, a medication for opioid use disorder. The research investigates improvements to a digital tool called EMBED CDS, which aids doctors in diagnosing opioid use disorder and initiating treatment. The trial will test various strategies, such as prompts for nurses and doctors, to enhance the tool's effectiveness and user-friendliness. Individuals visiting emergency departments with moderate to severe opioid use disorder may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative solutions that could improve emergency care for opioid use disorder.

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

The trial does not specify if you need to stop taking your current medications, but it does exclude those who are already receiving medication for opioid use disorder.

What prior data suggests that this clinical decision support system is safe for use in emergency departments?

Studies have shown that buprenorphine can safely reduce cravings and the risk of overdose for people with opioid use disorder (OUD). This treatment is generally well-tolerated and safe. Research indicates that using a tool like EMBED in emergency departments helps doctors quickly determine if buprenorphine suits a patient, leading to better outcomes. This tool streamlines the process and enhances safety. Feedback suggests that these tools effectively support safe treatment choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how buprenorphine, a key treatment for opioid use disorder (OUD), is initiated in emergency departments. Unlike standard treatments that may not fully integrate technology to aid decision-making, this trial explores an optimized Clinical Decision Support (CDS) system to enhance usability and workflow. By refining the CDS interface, the trial hopes to reduce user errors and task disruptions, making buprenorphine administration more efficient and accessible. This could lead to higher rates of treatment initiation and better outcomes for patients with OUD.

What evidence suggests that the EMBED CDS is effective for opioid use disorder?

Research has shown that buprenorphine can reduce cravings, overdoses, and deaths in people with opioid use disorder (OUD). This trial evaluates the EMBED CDS tool, which assists doctors in starting buprenorphine treatment for OUD patients in emergency rooms. Although some studies found no change in the frequency of buprenorphine treatment initiation, the tool is designed to aid in diagnosing OUD and support treatment decisions. This system aims to streamline and enhance the process for doctors to help patients begin their recovery journey. ^{1 4 6 7 8}

Who Is on the Research Team?

Edward Melnick, MD, MHS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for emergency department physicians to help them follow standard care when giving buprenorphine to patients with opioid use disorder. It's not specified who can't join, but typically those not involved in ED care or without opioid use disorder would be excluded.

Inclusion Criteria

Emergency department patient

Moderate to severe opioid use disorder

Exclusion Criteria

Pregnant

Currently receiving medication for opioid use disorder

Timeline for a Trial Participant

Preparation

Preparation phase for the Multiphase Optimization STrategy (MOST) framework study

Not specified

Optimization Phase, Stage 1

Conduct a 2x2x2 factorial trial to expand EMBED with sustainable implementation strategies

Not specified

Optimization Phase, Stage 2

Improve CDS usability via serial randomized testing to refine the CDS interface and workflow

Not specified

Evaluation Phase

Conduct a randomized trial to compare the efficacy of the optimized package on ED-initiation of buprenorphine rates

Up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EMBED CDS

Trial Overview The study tests an optimized clinical decision support system (EMBED) that aids in diagnosing opioid use disorder, assessing withdrawal severity, and encouraging treatment acceptance. The effectiveness of the improved EMBED will be compared to the original through a randomized trial.

How Is the Trial Designed?

Group I: Optimization Phase, Stage1: Factorial Trial Experimental Treatment 4 Interventions

Successful completion of Optimization Phase, Stage 1 Successful completion of the 2x2x2 factorial trial in which investigators expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment.

Group II: Optimization Phase, Stage 2: Rapid serialized testing Experimental Treatment 2 Interventions

Successful completion of Optimization Phase, Stage 2: Improve CDS usability via serial randomized testing to inform iterative refinement of the CDS interface and workflow to minimize user errors, task disruption, and abandonment through identification of specific targets for improvement via application of novel CDS outcome measures in serial randomized tests.

Group III: Evaluation Phase Experimental Treatment 2 Interventions

Successful completion of the Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The OUD-CDS tool was successfully developed and demonstrated to be functional and accurate, helping primary care providers (PCPs) identify and manage patients at risk for opioid use disorder (OUD).

Although the tool improved PCP confidence in screening and diagnosing OUD, it was used in only 5% of encounters with at-risk patients, indicating a need for better integration into primary care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the functionality and clinician acceptance of a clinical decision support tool to improve primary care of opioid use disorder. Rossom, RC., Sperl-Hillen, JM., O'Connor, PJ., et al.[2021]

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

This trial aims to evaluate the effectiveness of a user-centered clinical decision support (CDS) system in increasing the initiation of buprenorphine (BUP) treatment for individuals with opioid use disorder (OUD) in 20 emergency departments over 18 months.

The primary outcome will measure the rate of BUP initiation in the emergency department, while secondary outcomes will assess referral rates and clinician adherence to the CDS, ensuring a comprehensive evaluation of the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. Melnick, ER., Jeffery, MM., Dziura, JD., et al.[2023]

Buprenorphine implants were found to be noninferior to daily sublingual buprenorphine in maintaining opioid abstinence over a 6-month period, with 85.7% of implant users remaining abstinent compared to 71.9% of those on sublingual treatment.

The study involved 177 participants and showed that both treatment methods had similar response rates, but the implant group experienced fewer non-implant-related adverse events, suggesting a potentially safer option for long-term maintenance treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial. Rosenthal, RN., Lofwall, MR., Kim, S., et al.[2016]

The novel weekly subcutaneous buprenorphine depot formulation, CAM2038, was found to effectively block the euphoric effects of opioids and suppress withdrawal symptoms in individuals with moderate-to-severe opioid use disorder, based on a study involving 47 participants.

Both doses of CAM2038 (24 mg and 32 mg) were well-tolerated and demonstrated significant efficacy in preventing opioid effects, making it a promising alternative to daily oral formulations that carry risks of misuse and nonadherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. Walsh, SL., Comer, SD., Lofwall, MR., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7164817/

A Pragmatic Trial of User-Centered Clinical Decision Support ... Buprenorphine (BUP) can safely and effectively reduce craving, overdose, and mortality rates in people with opioid use disorder (OUD).

2. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/demonstration-projects/ug3-project-pragmatic-trial-of-user-centered-clinical-decision-support-to-implement-emergency-department-initiated-buprenorphine-for-opioid-use-disorder-embed/

UH3 Project: Pragmatic Trial of User-Centered Clinical ... The primary study outcome was the rate of buprenorphine administration or prescription in the ED among patients with opioid use disorder. Secondary ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811640

Adoption of Emergency Department–Initiated ... ... Opioid Use Disorder (EMBED) Trial. This trial examined the effect of a user-centered clinical decision support (CDS) intervention in a ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/15/2/e098072

Adaptive decision support for addiction treatment to ... 25 The EMBED trial evaluated the effectiveness of non-interruptive, EHR-based, clinical decision support (CDS) to facilitate patient assessment and EHR ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12431813/

A Measurement Science Framework to Optimize CDS for ... In the emergency department-initiated buprenorphine for opioid use disorder (EMBED) trial, a clinical decision support (CDS) tool had no effect on rates of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6414819/

Computerized Clinical Decision Support System for ... This study aimed to design and formatively evaluate a user-centered decision support tool for ED initiation of BUP for patients with OUD.

7. hd2arasc.org hd2arasc.org/innovation-and-acceleration-projects/improving-pain-management-and-opioid-safety-through-a-systemwide-data-driven-evaluation-of-the-cdc-opioid-prescribing-guideline-best-practices-and-the-use-of-clinical-decision-support/

Improving Pain Management and Opioid Safety Through a ... This project will foster a data-driven learning health system by linking Prescription Drug Monitoring Program, insurance claims, and death data to evaluate ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04918355

Study Details | NCT04918355 | A Health System Wide ... The use of focused CDS tools is associated with better patient outcomes: decreasing high-risk, long-term, and aberrant opioid use. Specifically, we will test ...