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Enrolling By Invitation
NCT05644587
Novel Induction to Buprenorphine/Naloxone
Conditions: Opioid Use Disorder, Opioid Use, Opioid Abuse, Opioid Misuse, Opioid Dependence
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 170
Sponsor: Bicycle Health
Location: United States
Summary
Microdosing induction is a novel method of starting buprenorphine/naloxone without patients experiencing the opioid withdrawal that is a part of traditional induction.
Patients take small doses of buprenorphine/naloxone that increase slowly over a week.
Although microdosing induction has been supported anecdotally, its effectiveness is not known.
The proposed study will compare the effectiveness and safety of two induction strategies for transitioning patients from opioids to buprenorphine/naloxone.
All inductions will occur in an outpatient telehealth opioid use disorder (OUD) treatment setting.
The study will compare patients who receive traditional induction versus microdosing induction.
Primary outcomes include effectiveness and safety.
Secondary outcomes include treatment retention, self-reported use of opioids during induction, return to opioid use, opioid appearance in drug screens, craving/withdrawal symptoms, and patient satisfaction.
Eligibility Criteria
Inclusion Criteria:Enrollment with Bicycle Health servicesAged 18 years old or olderDiagnosis of opioid use disorder confirmed by DSM-5 criteriaIn no/mild withdrawal at the time of intakeNeed to undergo induction to buprenorphine from a full opioid agonistUse of full opioid agonists not directly from a pharmacy within the last 24 hoursPharmacy stock check of 2 mg film/tablet done before visitWillingness and ability to follow study protocols, and the ability to provide informed consentExclusion Criteria:Known allergy or sensitivity to buprenorphine/naloxoneAny circumstance that precludes the need for inductionIn moderate to severe withdrawal at the time of intakeSevere or complex medical/psychiatric comorbidity that requires a customized induction schedule or surveillanceAny element that would exclude an individual from Bicycle Health services in general (e.g., homelessness, severe untreated mental illness)Patients requesting specific induction techniquePatients who are pregnant or lactating
Source: ClinicalTrials.gov (NCT05644587). StuddyBuddy aggregates publicly available trial information.
