Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Low-dose Buprenorphine Initiation for Opioid Use Disorder

NCT05450718

Opioid Use Disorder

RECRUITING PHASE4

Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder

NCT06086275

Opioid Use Disorder

COMPLETED PHASE1

Buprenorphine Dose Alteration Study - 1

NCT00000219

Opioid-Related Disorders

COMPLETED PHASE1

Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

NCT00134914

Opioid-Related Disorders

COMPLETED NA

Alternate-Day Buprenorphine Administration. Phase VIII - 9

NCT00000227

Opioid-Related Disorders

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use Disorder Opioid Withdrawal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Buprenorphine Microdosing

Participants transitioning to buprenorphine from methadone using a microdosing protocol.

Buprenorphine/naloxone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Buprenorphine/naloxone

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No