Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

NCT05307458 — Unknown, 20 participants, United Health Services Hospitals, Inc.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT05307458
Status	Unknown
Study type	Observational
Enrollment	20 (Estimated)
Sponsor	United Health Services Hospitals, Inc. (Other); collaborators: Binghamton University
Conditions	Opioid Use Disorder, Opioid Withdrawal
Interventions	Buprenorphine/naloxone (Drug)
Dates	start 2022-07-01, primary completion 2024-06-30 (estimated), completion 2024-12-31 (estimated), first posted 2022-04-01, last updated 2023-05-26
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Buprenorphine Microdosing		Drug: Buprenorphine/naloxone	Participants transitioning to buprenorphine from methadone using a microdosing protocol.

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

+Outcome measures

Primary outcomes

Opioid withdrawal symptoms [14-days]: Opioid withdrawal symptoms will be measured using the clinical opiate withdrawal scale (COWS) score and subjective opiate withdrawal scale (SOWS) score.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
UHS Addiction Medicine	Binghamton, New York	United States	Recruiting

My Notes

Public

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