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

Opioid-use Disorder Clinical Trial

— BOPAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677114
• Other study ID #: 60903
• Secondary ID: 1R01DA048892
• Status: Recruiting
• Phase: Phase 2
• Start date: March 16, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Kentucky
• Contact: Laura Fanucchi
• Phone: 859-323-1982
• Email: laura.fanucchi[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Use
• Infections
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Drug:
• Buprenorphine and Outpatient Parenteral Antibiotic Therapy
Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.
• Buprenorphine and standard of care antibiotic treatment
All participants will receive treatment of OUD and the infection per usual clinical care.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Laura Fanucchi	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Illicit Opioid Use	Proportion of urine samples with negative urine drug screen for illicit opioid use	12 weeks after hospital discharge
Secondary	Completion of Recommended IV Antibiotic Therapy	Proportion of patients who completed of recommended IV antibiotic therapy	up to 12 weeks (duration of IV antibiotic course as determined by treating physician)
Secondary	Abstinence From Illicit Opioid	Self-reported number of days of illicit opioid abstinence	12 weeks after hospital discharge
Secondary	Abstinence from Injection Drug Use	Self-reported number of days without injection use of any drug	12 weeks after hospital discharge
Secondary	Outpatient Treatment Retention	Number of days patients remain in treatment.	12 weeks after hospital discharge