Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)
Condition: Opioid Use Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to assess the clinical utility, effectiveness, and cost implications
      of treatment for incarcerated offenders with opioid use disorders who are randomly assigned
      to one of three treatment conditions to include a depot formulation of naltrexone (XR-NTX, as
      Vivitrol®) only (XR-NTX), Vivitrol provided with sessions with a patient navigator (PN)
      XR-NTX+PN, and a drug education procedure (ETAU) before being released to the community. This
      trial will investigate whether effective medication therapy used in non-incarcerated
      populations will also be effective in incarcerated individuals. Empirical evidence
      demonstrates that starting treatment before release greatly increases the probability of
      successful outcome including reduced alcohol and drug use, increased employment rates, and
      reduced recidivism rates.
    

Detailed description: 
      This randomized, open-label trial will examine the feasibility, efficacy, and net economic
      benefits of XR-NTX for opioid addiction delivered with and without a platform of PN provided
      for six months compared against an education (ETAU) condition. Before release from jail,
      participants in the XR_NTX and XR-NTX+PN conditions will receive their first Vivitrol
      injection (and those in the XR-NTX+PN condition will meet with a Patient Navigator) and will
      then be scheduled for medication management sessions twice monthly for months 1-3, with
      monthly injections in months 4-6. Participants in the XR-NTX+PN condition will meet with a PN
      who will provide behavioral assistance to overcome possible barriers to community outpatient
      treatment and will be provided with referrals for community treatment programs. Participants
      in the ETAU condition will receive education designed to reduce the likelihood of overdose on
      the same schedule as the XR-NTX and XR-NTX+PN groups.

      Participants will be individuals who meet DSM-5 (Diagnostic and Statistical Manual-5) (via
      CIDI-2 (composite international diagnostic interview

      )) criteria for opioid use disorders, are 18 years and older, who have been detoxified from
      opioids in the Metropolitan Detention Center in Albuquerque, New Mexico. This study will
      include only those participants for whom the study physician determines that possible
      treatment with the study drug is in the best interest, and informed consent will be obtained.

      All participants will be scheduled for twice-monthly medical management and assessment
      appointments for the first three months of the 24-week post-release intervention phase, with
      monthly appointments for months 4-6. Eligible participants will be randomly assigned to
      treatment condition (XR-NTX, XR-NTX+PN, ETAU) in equal numbers. XR-NTX and XR-NTX+PN
      participants will undergo a naloxone challenge to ensure opioid abstinence at the time of
      Vivitrol induction. Those in the XR-NTX+PN condition will be provided with a PN (patient
      navigator) who will facilitate attendance at outpatient treatment programs as well as assist
      with other needs. The ETAU group will not receive any medication but will be scheduled for
      assessments and education on drugs of abuse, maintaining abstinence, and methods for avoiding
      overdoses on the same schedule as the other two groups. All groups will also be provided with
      referrals to community-based substance abuse treatment programs.
    

Intervention name(s): XR-NTX; XR-NTX+PN; ETAU
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.; In addition to long-acting naltrexone (XR-NTX), participants assigned to the XR-NTX+PN condition will meet regularly with a patient navigator to assist in accessing psychosocial services when released from jail.; Participants assigned to the ETAU group will receive drug education.
Other intervention name(s): long-acting naltrexone; Vivitrol; Patient Navigator; Treatment-as-usual; Drug Education
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid Use; Incarceration; Vivitrol; Patient Navigator; Drug Education