Buprenorphine Treatment for Opioid Use Disorder

Recruiting at 3 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

330 Participants Needed

Trial Summary

What is the purpose of this trial?

A multisite effectiveness-implementation study will be conducted in three sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment of Black persons with OUD. The investigators hypothesize that treatment with the Better Together Integrated Collaborative Community MOUD care model (BT-MOUD) will result in better retention in treatment than standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) through 24 weeks following randomization. BT-MOUD provides MOUD with buprenorphine in nonmedical community-based settings via telemedicine from a hub buprenorphine clinic combined with Recovery Guiding, a manual guided coaching developed for this approach, provided onsite in the community organization.

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.

What data supports the effectiveness of the drug Buprenorphine for treating opioid use disorder?

Research shows that keeping patients on buprenorphine treatment for opioid use disorder helps reduce the harms associated with opioid use. Additionally, a study found that using video to observe patients taking buprenorphine may lead to better outcomes compared to usual treatment methods. ^{1 2 3 4 5}

Is buprenorphine safe for humans?

Research shows that buprenorphine, used in a patch form for pain management, has been studied for safety in various conditions, including chronic pain and opioid use disorder. It is generally considered safe for humans, but like any medication, it may have side effects, and its use should be monitored by a healthcare professional. ^{1 6 7 8 9}

How is the drug Buprenorphine Treatment for Opioid Use Disorder different from other treatments?

Buprenorphine Treatment for Opioid Use Disorder is unique because it can be administered as a sustained release formulation, which helps prevent misuse and nonadherence that can occur with daily oral forms. This approach may improve treatment retention and reduce the harms associated with opioid use disorder. ^{1 5 10 11 12}

Research Team

Niranjan Karnik, MD, PhD

Principal Investigator

University of Illinois Chicago

Richard S Schottenfeld, MD

Principal Investigator

Howard University

Viviana Horigian, MD, MHA

Principal Investigator

University of Miami

Denise M. Scott, PhD

Principal Investigator

Howard University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Buprenorphine use and courses of care for opioid use disorder treatment within the Veterans Health Administration. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Long-term treatment outcomes in a First Nations high school population with opioid use disorder. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Retrospective analysis of 4 years of clinical experience with transdermal buprenorphine (Transtec) in post-traumatic pain. [2014]

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

Buprenorphine transdermal system utilization. [2017]

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

Buprenorphine transdermal delivery system in adults with persistent noncancer-related pain syndromes who require opioid therapy: a multicenter, 5-week run-in and randomized, double-blind maintenance-of-analgesia study. [2022]

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

Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain. [2022]

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

Safety of buprenorphine transdermal system in the management of pain in older adults. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Buprenorphine transdermal system and quality of life in opioid-experienced patients with chronic low back pain. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Nonopioid Substance Use among Patients Who Recently Initiated Office-based Buprenorphine Treatment. [2023]

11. 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]

12. England pubmed.ncbi.nlm.nih.gov

Buprenorphine-naloxone treatment responses differ between young adults with heroin and prescription opioid use disorders. [2018]