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NCT05450718PHASE4Recruiting

Low-dose Buprenorphine Initiation for Opioid Use Disorder

Montefiore Medical Center

Start Date

11/11/2024

Completion Date

6/30/2027

Summary

The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.

Detailed Description

After being informed about the study and potential risks, all participants will be given written informed consent. Eligible participants will be randomized in a 1:1 ratio to an 8-day low-dose buprenorphine initiation protocol or treatment as usual, and conduct study visits at baseline and weeks 2 and 4. The investigators will also provide participants with mobile phones to collect real-time data on withdrawal, anxiety, craving and substance use through electronic Ecological Momentary Assessment (EMA) technology.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Any gender, aged 18 years or greater 4. Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria) 5. Ability to take sublingual medication 6. Willingness to adhere to the assigned buprenorphine initiation regimen 7. Fluency in English or Spanish 8. For participants of reproductive potential: agreement to use highly effective contraception during study participation Exclusion Criteria: 1. Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone 2. Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria) 3. Severe untreated mental illness, meaning psychosis or suicidality 4. Presence of an acute or chronic medical condition that would make participation medically hazardous 5. Pregnancy or lactation 6. Known allergic reactions to buprenorphine or naloxone 7. Inability to consent due to cognitive impairment

Interventions

DRUG

buprenorphine-naloxone

DRUG

buprenorphine-naloxone

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Conditions

Opioid Use Disorder

Locations

Montefiore Medical Center

The Bronx, New York 10467

United States