Recruiting

Buprenorphine

Sponsor:

United Health Services Hospitals, Inc.

Code:

NCT05307458

Conditions

Opioid Use Disorder

Opioid Withdrawal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine/naloxone

Study Details

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

Study ID

NCT05307458

Start date

Jul 1, 2022

Status verified date

May, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Buprenorphine Microdosing

Participants transitioning to buprenorphine from methadone using a microdosing protocol.

Interventions

Buprenorphine/naloxone

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

Primary outcome measure

  • Opioid withdrawal symptoms [ Time Frame: 14-days ]

Central Contacts and Locations

Central contacts

William Eggleston, PharmD

607-777-5848wegglest@binghamton.edu

Terri K Peters, RN MSN CCRP

6077635697terri.peters@nyuhs.org

Locations

UHS Addiction Medicine

Recruiting

Binghamton, New York, United States, 13903

Contacts

Terri K Peters, RN MSN CCRP

607-763-5697terri.peters@nyuhs.org

More Information

Sponsor

United Health Services Hospitals, Inc.

Last update posted

May 26, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United Health Services Hospitals, Inc. on 2023-05-26.