Clinical Trial: Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Feasibility Study for Testing the Effects of Extended-release Naltrexone (Vivitrol) on Recidivism and Other Participant Outcomes in Drug Court Settings

Brief 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 Summary:

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. Any drug court clients who are insured, and thereby do have access to Vivitrol®, will not be eligible for this study.) 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
Sponsor: Duke University

Current Primary Outcome:

  • New arrests [ Time Frame: 12 months ]
    New arrests (number of arrests, types of charges) during the 12-month study period. This information will be collected from administrative records.
  • New incarcerations [ Time Frame: 12 months ]
    New incarcerations (number, length, and types of charges) during the 12-month study period. This information will be collected from administrative records.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of positive drug screens [ Time Frame: 12 months ]
    Number of times a client had a positive drug screen. This information will be collected from administrative records.
  • Number of sanctions imposed by the court [ Time Frame: 12 months ]
    Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records.
  • Number of missed court appointments [ Time Frame: 12 months ]
    Number of missed court appointments during the 12-month study period. This information will be collected from administrative records.
  • Vivitrol participation [ Time Frame: 12 months ]
    Number/timing of Vivitrol injections, for Vivitrol arm only. This information will be collected from administrative records.
  • Treatment participation (non-Vivitrol) [ Time Frame: 12 months ]
    Number/timing/type of other (non-Vivitrol) treatment participation for all participants in both arms of study. This information will be collected from administrative records.
  • Change in subjective functioning: medical status [ Time Frame: Approximately 6 months ]
    Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
  • Change in subjective functioning: employment/support status [ Time Frame: Approximately 6 months ]
    Subjective assessment of employment and support status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
  • Change in subjective functioning: alcohol/drug use [ Time Frame: Approximately 6 months ]
    Subjective assessment of alcohol/drug use using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
  • Change in subjective functioning: legal status [ Time Frame: Approximately 6 months ]
    Subjective assessment of legal status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
  • Change in subjective functioning: family/social relationships [ Time Frame: Approximately 6 months ]
    Subjective assessment of family and social relationships using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
  • Change in subjective functioning: psychiatric status [ Time Frame: Approximately 6 months ]
    Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
  • Treatment satisfaction [ Time Frame: Approximately 6 months ]
    Satisfaction with treatment as reported by subject in follow-up interview to occur about 6 months after the baseline interview.
  • Treatment attitudes [ Time Frame: Approximately 6 months ]
    Attitudes toward Vivitrol and other forms of medication-assisted treatment for opioid dependence, to be measured via interview at baseline and approximately six months.


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: November 28, 2016
Date Started: June 2017
Date Completion: March 2019
Last Updated: May 2, 2017
Last Verified: October 2016