Rapid Initiation of Drug Treatment Engagement
Condition: Opioid-use Disorder; Overdose
MeSH terms: Opioid-Related Disorders; Drug Overdose
Intervention: buprenorphine/naloxone
Intervention description: A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager. The team will rapidly confirm opioid use disorder and risk of overdose, complete informed consent, and begin induction procedures for a "transitional" (one month) course of buprenorphine/naloxone treatment. During this time, the dedicated case manager and PRS will work with the participants to help them become engaged in existing medication assisted treatment programs
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opiate use disorder; overdose; medication assisted treatment

Summary:

      The proposed research will evaluate the ability of a mobile, rapid induction procedure to
      engage individuals in ongoing medication assisted treatment. A total of 250 untreated
      individuals meeting criteria for opioid use disorder and at high risk of opioid overdose will
      be enrolled in the study. Recruitment will take place in two targeted neighborhoods of
      Philadelphia (Kensington and South Philadelphia) with a high prevalence of fatal and
      non-fatal opioid overdose. A total of 250 participants will be engaged in the research.
      Following informed consent and determination of eligibility, 125 individuals will be enrolled
      as they engage with the mobile, rapid induction team and 125 individuals will be enrolled as
      they seek treatment from the CRC Episcopal Hospital (serving Kensington area) or BAC/CRC Hall
      Mercer Community Mental Health (serving South Philadelphia). The intervention group will
      receive four weeks of treatment with buprenorphine /naloxone and support for treatment
      engagement provided by a case manager and a peer recovery specialist. All participants will
      be assessed at baseline and then 1- and 6-month following enrollment. The primary endpoint
      for the study is continued enrollment in medication-assisted treatment at 6-month
      post-enrollment.

      The proposed research will evaluate the ability of a mobile, rapid induction procedure to
      engage individuals in ongoing medication assisted treatment.

      The specific aims are:

        -  Aim 1: To evaluate the impact of the mobile, transitional MAT intervention on its
           ability to engage participants in targeted, existing MAT treatment slots at 1- and
           6-month post-enrollment.

        -  Aim 2: To evaluate the impact of the mobile intervention on subsequent drug use and
           overdoses at 6-month post-enrollment.

        -  Aim 3: To assess the acceptability and costs of the intervention. The program and
           patient costs of delivering and participating in the intervention will be documented.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 18 years of age or older

          -  Opioid overdose in the prior 12 months

          -  Meet criteria for opioid use disorder

          -  Resident of Philadelphia

          -  Willingness and ability to participate in study procedures

        Exclusion Criteria:

          -  Inability to comprehend or complete study procedures

          -  Plans to relocate during study time frame

          -  Currently in medication assisted treatment (MAT) for substance use disorder

          -  Evidence of serious liver disease (LFTs > 3 x the upper limit of normal)

          -  Pregnancy or lactation

          -  Moderate to severe alcohol or benzodiazepine use disorder