drugset / Trial / NCT05644587

Novel Induction to Buprenorphine/Naloxone

NCT05644587 ↗

Phase 4 Terminated 33 enrolled Bicycle Health
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-02-06
Primary completion
2023-11-30
Completion
2023-11-30

Outcome

Outcome not reported

Stopped (Enrollment): “Low enrollment numbers”

Drugs

EvaluationDrugModalityDoseRoute
Comparator buprenorphine/naloxone Unknown 12 mg Other