Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness
      in drug courts, investigators propose a feasibility study in the Wake County, North Carolina
      drug court, where an estimated 50% of clients are opioid dependent.

      Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and
      eligible clients of the Wake County Drug Court.
    

Detailed description: 
      Aim 1. Pilot RCT. The pilot delivery of Vivitrol® in the Wake County Drug Court will be
      carried out with 20-40 eligible drug court clients under treatment by Fellowship Health
      Resources, Inc. (FHR), the community behavioral health treatment agency that is the
      contracted treatment provider for the Wake County Drug Court. Participants will be randomized
      in equal number to receive Vivitrol® plus treatment as usual (TAU) or TAU only. TAU for drug
      court clients receiving services at FHR includes psychosocial treatment such as individual or
      group therapy, and sometimes also oral naltrexone for clients who are medically eligible and
      interested in taking the medication, the cost of which is covered by the agency for uninsured
      clients. (FHR currently administers Vivitrol® for a small number of interested agency clients
      with health insurance that covers the medication; the vast majority of their drug court
      clients are uninsured and so have no real access to the extended-release formulation due to
      its high cost.) Vivitrol® is an FDA-approved extended-release injectable form of naltrexone.
      Naltrexone is also available in oral, but not extended release, form. Naltrexone is an opioid
      antagonist that "blocks" opioid receptors in the brain to stop pleasurable feelings
      associated with taking opioids. Potentially eligible subjects will be drug court-referred FHR
      clients willing and eligible to take Vivitrol®, and willing to be randomly assigned to
      Vivitrol® or TAU. Potential subjects already under treatment with oral naltrexone at FHR
      would be eligible to enter the study if willing to switch to injectable Vivitrol® if randomly
      assigned. Study subjects who are randomized to Vivitrol® would receive a once-monthly
      injection of Vivitrol® for 12 months, or less if they decide to stop receiving Vivitrol® or
      to drop out of the study. Those randomized to TAU would continue with treatment as before,
      which could including (1) staying on oral naltrexone if already on it, (2) considering
      starting oral naltrexone, if interested, or (3) continuing with psychosocial treatment only.
      The Vivitrol® will be administered by study medical personnel at FHR. Randomization to the
      Vivitrol® arm would add urine pregnancy testing to FHR's existing Vivitrol® medical
      evaluation protocol and consent process, which currently screens for pregnancy without
      requiring a urine test. A urine pregnancy test will be administered once per month for female
      study participants of child-bearing age who are in the Vivitrol® group. All drug court
      clients, including study participants in both study groups, have urine drug tests at least
      once per week as part of program participation.

      In addition to participating in Vivitrol® and psychosocial treatment, pilot RCT participants
      will provide consent for FHR and the drug court to share information with the study team
      about their demographic and clinical characteristics, treatment participation (e.g.,
      outpatient group therapy), and court-related events (e.g., type of conviction that led to
      their drug court participation, missed drug court appointments, sanctions for program
      violations, and the results of drug screens).

      Participants will also provide two face-to-face interviews at baseline and 6 months after
      baseline, about their interest and experience in Vivitrol® and/or other medication-assisted
      treatment (MAT), other treatment preferences, level of functioning, quality of life, and
      engagement in employment or education.

      Outcome measures include treatment participation, compliance with drug court conditions,
      arrests and incarcerations, treatment satisfaction, and self-reported subjective measures of
      functioning and quality of life.

      If a participant chooses not to participate in the study at any time, it will not affect
      his/her relationship with the court, FHR, right to health care, or participation in the study
      interview data collection. Site staff will follow participants for the purposes of collecting
      research and safety information. Investigators discontinue Vivitrol® or oral naltrexone in
      circumstances such as: adverse reactions to the medication; a change in medical status that
      makes it unsafe for a participant to continue receiving the medication, including pregnancy;
      or a participant becoming ill during the study. Participants who discontinue Vivitrol® or
      oral naltrexone for any reason may continue to participate in interviews for the study.
    

Intervention name(s): Naltrexone for extended-release injectable suspension; Oral naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing.; Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Other intervention name(s): Vivitrol; Revia
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Medication-assisted treatment; Drug Court; Pilot study; Opioid dependence; Criminal justice