Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

NCT05307458 | Unknown FDA Drug

• 1 other identifier: 11453
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acute Precipitated Withdrawal

  14-days

• Treatment retention

  6-months

• Area Under the Curve

  14-days

• Peak concentration

  14-days

Study Arms (1)

Buprenorphine Microdosing

Participants transitioning to buprenorphine from methadone using a microdosing protocol.

Drug: Buprenorphine/naloxone

Interventions

Buprenorphine/naloxone DRUG

Participants will receive gradually increasing doses of buprenorphine while tapering down on their methadone dose.

Buprenorphine Microdosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Health Services Hospitals, Inc.: lead
• Binghamton University: collaborator

Study Sites (1)

UHS Addiction Medicine

Binghamton, New York, 13903, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

William Eggleston, PharmD

CONTACT

607-777-5848; wegglest@binghamton.edu

Terri K Peters, RN MSN CCRP

CONTACT

6077635697; terri.peters@nyuhs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 1, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)