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

Trial Summary

What is the purpose of this trial?

This study refines and optimizes the EMBED\* clinical decision support (CDS; see NCT03658642) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. Optimization Phase: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED is expanded to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompts to use the CDS along with individualized patient resources to promote equity and motivate readiness to start treatment. In Stage 2, investigators will 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. Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD. \*EMBED is a user user-centered, clinician clinician-facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community

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 data supports the effectiveness of the drug buprenorphine for opioid use disorder?

Research shows that using a clinical decision support system in emergency departments can help doctors start buprenorphine treatment more effectively for people with opioid use disorder. This system makes it easier for doctors to use buprenorphine, which is known to help reduce opioid use when patients stick to the treatment. ^{1 2 3 4 5}

Is buprenorphine safe for humans?

Buprenorphine is generally considered safe for treating opioid use disorder, with studies showing it has a lower risk of causing breathing problems compared to other treatments like methadone. Long-term safety data for weekly and monthly injections also support its safe use in adults. ^{4 6 7 8 9}

How is the EMBED CDS treatment for opioid use disorder different from other treatments?

The EMBED CDS treatment is unique because it uses a user-centered computerized clinical decision support system to help emergency department clinicians initiate buprenorphine treatment for opioid use disorder, addressing barriers like unfamiliarity and perceived complexity. ^{1 2 5 10 11}

Research Team

Edward Melnick, MD, MHS

Principal Investigator

Yale University

Eligibility Criteria

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

I am 18 years old or older.

Moderate to severe opioid use disorder

Exclusion Criteria

Pregnant

Currently receiving medication for opioid use disorder

I am younger than 18.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

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

Interrupted Time Series of User-centered Clinical Decision Support Implementation for Emergency Department-initiated Buprenorphine for Opioid Use Disorder. [2021]

2. England 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. [2023]

3. United States 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. [2016]

4. Netherlands 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. [2023]

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

Novel Formulations of Buprenorphine for Treatment of Opioid Use Disorder. [2020]

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

Buprenorphine implants in medical treatment of opioid addiction. [2017]

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

Evaluation on drug dependence of buprenorphine. [2013]

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

Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder. [2021]

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

Oral buprenorphine utilization, concomitant benzodiazepines and opioid analgesics, and payment source: Trends from 2015 to 2019. [2023]

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

Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. [2020]

11. England 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. [2021]