Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Opioid Withdrawal
• Intervention / Treatment: Drug: Buprenorphine/naloxone

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: William Eggleston, PharmD; Phone Number: 607-777-5848; Email: wegglest@binghamton.edu
• Study Contact Backup: Name: Terri K Peters, RN MSN CCRP; Phone Number: 6077635697; Email: terri.peters@nyuhs.org

Study Locations

• United States
  • New York
    • Binghamton, New York, United States, 13903
      • Recruiting
      • UHS Addiction Medicine
      • Contact: Terri K Peters, RN MSN CCRP; Phone Number: 607-763-5697; Email: terri.peters@nyuhs.org
      • Contact: Kathy A Hughes, RN MS; Phone Number: 607-763-5368; Email: kathy.hughes@nyuhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants will include adults (at least 18 years of age) who have been enrolled and receiving consistent treatment in the methadone program for at least 6 months. Participants will be excluded if they are on a methadone dose > 80 mg, have concurrent alcohol use or benzodiazepine use disorder, require opioids for a pain-related diagnosis, are a current suicide or homicide risk, have a current psychotic disorder (DSM-V) or untreated major depression, have a life-threatening or unstable medical problem, or are pregnant.

Description

Inclusion Criteria:

• Participants will include adults (at least 18 years of age) who have been enrolled and receiving consistent treatment in the methadone program for at least 6 months.

Exclusion Criteria:

• Participants will be excluded if they are on a methadone dose > 80 mg, have concurrent alcohol use or benzodiazepine use disorder, require opioids for a pain-related diagnosis, are a current suicide or homicide risk, have a current psychotic disorder (DSM-V) or untreated major depression, have a life-threatening or unstable medical problem, or are pregnant.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Buprenorphine Microdosing; Participants transitioning to buprenorphine from methadone using a microdosing protocol.	Drug: Buprenorphine/naloxone; Participants will receive gradually increasing doses of buprenorphine while tapering down on their methadone dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid withdrawal symptoms	Opioid withdrawal symptoms will be measured using the clinical opiate withdrawal scale (COWS) score and subjective opiate withdrawal scale (SOWS) score.	14-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Precipitated Withdrawal	Severe opioid withdrawal symptoms resulting in hospitalization.	14-days
Treatment retention	Patient retention in the buprenorphine treatment program. Defined as continued treatment with buprenorphine.	6-months
Area Under the Curve	Buprenorphine AUC will be measured in participants.	14-days
Peak concentration	Buprenorphine peak concentrations will be measured in participants.	14-days

Collaborators and Investigators

• Sponsor: United Health Services Hospitals, Inc.
• Collaborators: Binghamton University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination
• Other Study ID Numbers: 11453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No