Novel Induction to Buprenorphine/Naloxone

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bicycle Health
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

• Enrollment with Bicycle Health services

• Aged 18 years old or older

• Diagnosis of opioid use disorder confirmed by DSM-5 criteria

• In no/mild withdrawal at the time of intake

• Need to undergo induction to buprenorphine from a full opioid agonist

• Use of full opioid agonists not directly from a pharmacy within the last 24 hours

• Pharmacy stock check of 2 mg film/tablet done before visit

• Willingness and ability to follow study protocols, and the ability to provide informed consent

Exclusion Criteria:

• Known allergy or sensitivity to buprenorphine/naloxone

• Any circumstance that precludes the need for induction

• In moderate to severe withdrawal at the time of intake

• Severe or complex medical/psychiatric comorbidity that requires a customized induction schedule or surveillance

• Any element that would exclude an individual from Bicycle Health services in general (e.g., homelessness, severe untreated mental illness)

• Patients requesting specific induction technique

• Patients who are pregnant or lactating