Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis (NCT03048643) | Clinical Trial Compass
CompletedNot Applicable
Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis
United States20 participantsStarted 2017-03-01
Plain-language summary
Hospitalizations for severe infections associated with opioid use disorder (OUD), such as infective endocarditis (IE), have doubled in the US over the past decade and are frequently prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons with IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more) largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional outpatient care program supporting MAT, may support provision of outpatient IV antibiotic therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE due to opioid use disorder in the hospital for the full duration of antibiotic treatment) compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically stable).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* meeting OUD by DSM-V criteria
* have IE by Duke's criteria
* candidates for outpatient treatment with buprenorphine
* accepting of buprenorphine treatment
* anticipated to be discharged home after medically stabilized
* requiring ≥ 2 weeks of IV antibiotic therapy
* having ≥ 1 week of IV antibiotic therapy remaining at the time of medical readiness for discharge (as defined by the primary clinical team),
* and providing informed consent.
Exclusion Criteria:
* presence of stroke or central nervous system involvement
* clinically active embolic sequelae (e.g. pulmonary sepsis, mycotic aneurysms, splenic abscesses)
* TV treated surgically or endovascularly (AngioVac)
* presence of osteomyelitis
* fungal IE
* patients who require inpatient physical rehabilitation determined by physical or occupational therapy assessment
* current pregnancy
* current severe methamphetamine, cocaine, alcohol or benzodiazepine use disorders by DSM-V criteria
* currently enrolled in ongoing MAT for OUD
* hypersensitivity or allergy to buprenorphine
* chronic pain requiring opioids
* class III or IV heart failure
* cirrhosis
* end stage renal disease
* other significant screening laboratory/medical/psychiatric/psychosocial condition that may prevent the volunteer from safely participating in the study in the opinion of the investigator (e.g. currently suicidal)
* pending legal action that could interfere with study participation
* living more than a 45-minute drive from UK giv…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.