Buprenorphine Treatment for Opioid Use Disorder

Not yet recruiting at 5 trial locations

Overseen By Niranjan Karnik, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Howard University

Must be taking: Buprenorphine

Disqualifiers: Cognitive impairment, Psychiatric condition, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two approaches to help individuals with Opioid Use Disorder (OUD) remain in treatment using buprenorphine, a medication that manages opioid addiction. One group receives standard care at a clinic, while the other accesses a community-based program with telemedicine and personalized support. The researchers aim to determine if the community-based approach extends treatment duration. This trial may suit someone recently prescribed buprenorphine and interested in exploring different support methods to manage their condition. As an unphased trial, it offers a unique opportunity to explore innovative support methods for managing 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. However, you must not have received medication for opioid use disorder (MOUD) in the 30 days before enrolling.

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

Research has shown that buprenorphine is generally safe and effective for treating opioid use disorder (OUD). Studies have found that it can lower the risk of hospital visits and emergencies. Specifically, long-term use of buprenorphine resulted in a significant 52% decrease in hospital admissions.

In large patient groups, such as a study involving over 255,000 veterans, many took buprenorphine without major problems. This treatment helps control cravings and withdrawal symptoms, common challenges in OUD.

Overall, buprenorphine is considered a safe option for OUD when used as directed. While some side effects may occur, serious issues are rare. Following medical advice and having support during treatment is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for opioid use disorder because they offer innovative approaches beyond the standard of care, typically involving medications like methadone, naltrexone, and sublingual buprenorphine. The HC-MOUD treatment utilizes buprenorphine with a potential shift to long-acting injections and the convenience of telemedicine, aligning with modern healthcare trends. The BT-MOUD treatment goes a step further by integrating Recovery Guiding, a structured intervention that provides educational and behavioral support, addressing common recovery challenges. This combination of medical and community-based support could enhance recovery outcomes, making these treatments promising options for improving the journey to recovery.

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

Research shows that buprenorphine, when combined with good quality, low-intensity counseling, effectively treats opioid use disorder (OUD). Studies have found that medications like buprenorphine significantly reduce the risk of death for individuals with OUD. In this trial, participants in the "Hub Clinic MOUD with buprenorphine only" arm will receive buprenorphine treatment in community settings, potentially including telemedicine as part of standard care. Meanwhile, participants in the "Recovery Guiding / Better Together Medications for Opioid Use Disorder" arm will receive buprenorphine treatment along with structured support and behavioral therapy, which can improve outcomes and encourage medication adherence. Overall, buprenorphine is a crucial treatment for OUD, and community support enhances its effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Richard S Schottenfeld, MD

Principal Investigator

Howard University

Niranjan Karnik, MD, PhD

Principal Investigator

University of Illinois Chicago

Viviana Horigian, MD, MHA

Principal Investigator

University of Miami

Denise M. Scott, PhD

Principal Investigator

Howard University

Are You a Good Fit for This Trial?

This trial is for African American individuals struggling with opioid use disorder (OUD). Participants should be interested in receiving treatment involving medication-assisted therapy with buprenorphine. Details on specific inclusion and exclusion criteria are not provided, but typically these would relate to health status, age, and other factors relevant to the study.

Inclusion Criteria

Willing and able to provide informed consent, and when applicable, signed assent (consent process)

I am considering and suitable for medication-assisted treatment with buprenorphine.

Self-identify race as Black (or African American, African, or Afro-Caribbean) (self report)

Exclusion Criteria

I am unable to understand and give consent due to cognitive or developmental issues.

Have a psychiatric, cognitive, or medical condition which would make participation inappropriate or contraindicated, as assessed by the hub buprenorphine clinic provider

Plan to move out of the area or do not anticipate being able to remain in the study for 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MOUD with buprenorphine, either through the BT-MOUD model or HC-MOUD Only, for retention in treatment

24 weeks

Telemedicine and in-person visits as per treatment model

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

• BT-MOUD with Buprenorphine
• HC-MOUD Only

Trial Overview

The study compares two approaches: standard care using buprenorphine at a clinic (HC-MOUD Only) versus a community-based model offering telemedicine and coaching support (BT-MOUD). The goal is to see which method keeps patients in treatment longer over a period of 24 weeks after they start.

How Is the Trial Designed?

Group I: Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures Experimental Treatment 1 Intervention

Better Together Medications for Opioid Use Disorder (BT-MOUD) includes HC-MOUD plus access to telemedicine provision of MOUD with buprenorphine at a nonmedical community organization spoke, plus manual-guided Recovery Guiding provided onsite at the spoke, and plus any other services available at the community organization spoke. Recovery Guiding is a manualized, highly structured, stepwise intervention that uses educational and behavioral tools to provide pragmatic guidance for patients beginning buprenorphine treatment and to address the key recovery misconceptions and dysfunctional behaviors that frequently interfere with recovery efforts of patients initiating medication for opioid use disorder (MOUD) treatment.

Group II: Hub Clinic MOUD with buprenorphine only (HC-MOUD Only) Active Control 1 Intervention

Participants will receive MOUD with buprenorphine prescribed by providers based at participating hub clinics. MOUD treatment with buprenorphine will follow standard guidelines for induction and maintenance using a sublingual buprenorphine formulation. Hub clinic buprenorphine providers and participants may shift to long acting injection buprenorphine formulations after initial induction with sublingual buprenorphine. If telemedicine prescribing of MOUD with buprenorphine is part of the usual standard of care at the clinic, participants assigned to HC-MOUD Only may be prescribed buprenorphine via telemedicine, following the clinic's usual guidelines. Participants may not receive telemedicine services at the community spokes or Recovery Guiding, which are available only to participants assigned to BTMOUD. All study participants, however, may have access to any services that are routinely provided as part of the MOUD with buprenorphine treatment-as-usual care in the hub clinic.

Who Is Running the Clinical Trial?

Howard University

Lead Sponsor

Trials

44

Recruited

15,200+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

University of Maryland

Collaborator

Trials

171

Recruited

325,000+

Published Research Related to This Trial

In a 12-week study involving patients with chronic low back pain, the Butrans® (buprenorphine) transdermal system at a higher dose (20 μg/h) significantly improved health-related quality of life compared to a lower dose (5 μg/h), particularly in areas like physical health and bodily pain.

The improvements in quality of life for patients receiving the higher dose were not only significant at 12 weeks but also maintained throughout a subsequent 52-week open-label extension phase, indicating long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine transdermal system and quality of life in opioid-experienced patients with chronic low back pain. Miller, K., Yarlas, A., Wen, W., et al.[2022]

A retrospective analysis of 6566 patients found that the buprenorphine transdermal system (BTDS) has a similar safety profile in older adults (≥ 65 years) compared to younger adults (< 65 years), with both groups experiencing a comparable incidence of adverse events (AEs).

While BTDS is generally effective for chronic pain management in older adults, it is associated with a higher risk of specific AEs like constipation and urinary tract infections, and caution is advised due to potential risks such as falls and injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of buprenorphine transdermal system in the management of pain in older adults. Pergolizzi, JV., Raffa, RB., Marcum, Z., et al.[2022]

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]

In a pilot study involving 78 adults with opioid use disorder, the use of video directly-observed therapy (DOT) for buprenorphine did not lead to better outcomes in terms of negative urine drug tests compared to standard treatment, with 50% negative tests in the video DOT group versus 64% in the treatment-as-usual group.

Engagement in treatment at week 12 was also lower in the video DOT group (69%) compared to the standard treatment group (82%), indicating that the video monitoring approach may not be more effective than traditional methods for supporting patients in their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial. Tsui, JI., Leroux, BG., Radick, AC., et al.[2022]

In a study of 255,726 Veterans with opioid use disorder (OUD), 15.8% received buprenorphine medication treatment (B-MOUD), with a significant increase in treatment courses over time, from 1550 in 2007 to 8146 in 2018.

Patients receiving B-MOUD had a median treatment duration of 157 days, with 33.8% undergoing multiple treatment courses, indicating that B-MOUD is a commonly utilized and persistent treatment option for managing OUD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine use and courses of care for opioid use disorder treatment within the Veterans Health Administration. Gordon, AJ., Saxon, AJ., Kertesz, S., et al.[2023]

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