Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

Opioid Use Disorder Clinical Trial

Official title:

Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307458
• Other study ID #: 11453
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: United Health Services Hospitals, Inc.
• Contact: William Eggleston, PharmD
• Phone: 607-777-5848
• Email: wegglest[@]binghamton.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid Withdrawal
• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine/naloxone
Participants will receive gradually increasing doses of buprenorphine while tapering down on their methadone dose.

Locations

Country	Name	City	State
United States	UHS Addiction Medicine	Binghamton	New York

Sponsors (2)

Lead Sponsor	Collaborator
United Health Services Hospitals, Inc.	Binghamton University

Country where clinical trial is conducted

United States, 

Outcome

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