Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections

NCT ID: NCT04677114

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2025-03-06

Brief Summary

This study will assess the efficacy of an integrated outpatient treatment model for persons with opioid use disorder and injection related infections. The investigators hypothesize that outpatient antibiotic treatment coupled with comprehensive treatment for opioid use disorder will demonstrate a safe and effective way to manage patients. Results could improve the current protocols for the treatment of individuals with opioid use disorder and severe infections.

Conditions

Drug Use; Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Outpatient Parenteral Antibiotic Therapy (OPAT)

Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).

Group Type: EXPERIMENTAL

Buprenorphine and Outpatient Parenteral Antibiotic Therapy

Intervention Type: DRUG

Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.

Treatment as Usual (TAU)

Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.

Group Type: ACTIVE_COMPARATOR

Buprenorphine and standard of care antibiotic treatment

Intervention Type: DRUG

All participants will receive treatment of OUD and the infection per usual clinical care.

Interventions

Buprenorphine and Outpatient Parenteral Antibiotic Therapy

Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.

Intervention Type: DRUG

Buprenorphine and standard of care antibiotic treatment

All participants will receive treatment of OUD and the infection per usual clinical care.

Intervention Type: DRUG

Other Intervention Names

Suboxone or Sublocade; Suboxone or Sublocade

Eligibility Criteria

Inclusion Criteria

• have opioid use disorder
• have a severe injection related infection requiring antibiotics
• willing to accept buprenorphine treatment
• anticipated to be discharged home
• require IV antibiotic therapy

Exclusion Criteria

• stroke or cerebral mycotic aneurysms preventing aortic or mitral valve surgery
• fungal valve IE
• requiring in-patient rehabilitation
• current pregnancy
• hypersensitivity or allergy to buprenorphine
• class III or IV heart failure
• end-stage liver or renal disease
• any condition that may prevent the volunteer from safely participating in the study
• self-report of desire to inject into the PICC line
• pending legal action that could interfere with study participation
• unsafe or unstable environment precluding safe administration of IV antibiotics
• living more than a 60 minute drive outside of Lexington, KY

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Laura Fanucchi

OTHER

Sponsor Role: lead

Responsible Party

Laura Fanucchi

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

References

Fanucchi LC, Murphy SM, Surratt H, Kapadia SN, Walsh SL, Grubbs JA, Thornton AC, Nuzzo P, Lofwall MR. Design and protocol of the Buprenorphine plus Outpatient Parenteral Antimicrobial Therapy (B-OPAT) study: a randomized clinical trial of integrated outpatient treatment of opioid use disorder and severe, injection-related infections. Ther Adv Infect Dis. 2022 Jul 11;9:20499361221108005. doi: 10.1177/20499361221108005. eCollection 2022 Jan-Dec.

Reference Type: BACKGROUND

PMID: 35847566 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DA048892

Identifier Type: NIH

Identifier Source: secondary_id

View Link

60903

Identifier Type: -

Identifier Source: org_study_id