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 Type
OBSERVATIONAL
Enrollment
20
Participants will receive gradually increasing doses of buprenorphine while tapering down on their methadone dose.
UHS Addiction Medicine
Binghamton, New York, United States
RECRUITINGOpioid withdrawal symptoms
Opioid withdrawal symptoms will be measured using the clinical opiate withdrawal scale (COWS) score and subjective opiate withdrawal scale (SOWS) score.
Time frame: 14-days
Acute Precipitated Withdrawal
Severe opioid withdrawal symptoms resulting in hospitalization.
Time frame: 14-days
Treatment retention
Patient retention in the buprenorphine treatment program. Defined as continued treatment with buprenorphine.
Time frame: 6-months
Area Under the Curve
Buprenorphine AUC will be measured in participants.
Time frame: 14-days
Peak concentration
Buprenorphine peak concentrations will be measured in participants.
Time frame: 14-days
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