Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)
Condition: Opioid Use Disorders
MeSH terms: Opioid-Related Disorders
Intervention: XR-NTX; XR-NTX+PN; ETAU
Intervention description: 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.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Opioid Use; Incarceration; Vivitrol; Patient Navigator; Drug Education

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be at least 18 years of age or older,

          2. Meet criteria for DSM-5 opioid use disorders,

          3. Be detained for at least 48 hours,

          4. Have an expected release date within one year,

          5. Plan to reside in area after release.

        Exclusion Criteria:

          1. Have a medical (e.g., liver failure, congestive heart failure) or psychiatric
             condition (e.g., suicidal ideation, psychosis) that would make participation unsafe in
             the judgment of the medical staff or the PI,

          2. Have current or chronic pain or have plans to undergo pain treatment/therapy,

          3. Have known sensitivity to naltrexone or naloxone,

          4. Have participated in an investigational drug study within the past 30 days prior to
             screening,

          5. Be a nursing or pregnant female, or not agree to use a medically acceptable form of
             birth control such as oral contraceptives, barrier (diaphragm or condom),
             levonorgestrel implant, intra-uterine progesterone contraceptives system,
             medroxyprogesterone acetate contraceptive injection, or complete abstinence. Females
             who become pregnant during the course of the study will be withdrawn from the study
             and, if requested, will be provided with referrals for drug treatment and/or medical
             care,

          6. Have any pending legal action that could prohibit continued participation for the
             24-week intervention period of the study, such as legal proceedings that could
             possibly result in incarceration,

          7. Have a current pattern of alcohol, benzodiazepine, or other depressant or sedative
             hypnotic use, as determined by the study physician which would preclude safe
             participation in the study.