NCT05307458

Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: United Health Services Hospitals, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

There are more than 2.1 million people in the United States with opioid use disorder, and according to preliminary data from the US Centers for Disease Control and Prevention opioid overdose deaths rose 36% to more than 69,000 deaths in 2020. Treatment with buprenorphine or methadone reduces overdose deaths in patients with opioid use disorder. However, most patients with opioid use disorder do not receive treatment. In addition to the rising rates of morbidity and mortality, the healthcare, social, and societal costs of the opioid epidemic are roughly one trillion dollars annually. Rapidly scalable strategies are needed to increase access to treatment and improve treatment retention. The investigators propose a novel buprenorphine micro-dosing study to evaluate the pharmacokinetics, treatment retention, and qualitative outcomes in participants transitioning from methadone maintenance therapy to buprenorphine using a micro-dosing initiation in the outpatient setting. The proposed study will report participant pharmacokinetics, treatment retention, Clinical Opiate Withdrawal Scale (COWS) score, Treatment Satisfaction Questionnaire for Medication (TSQM) score, and other qualitative outcomes.

Conditions

• Opioid Use Disorder
• Opioid Withdrawal

Interventions

Type	Name	Description
DRUG	Buprenorphine/naloxone	Participants will receive gradually increasing doses of buprenorphine while tapering down on their methadone dose.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2022-04-01
• Last updated: 2023-05-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study