NCT02978417

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid-Related Disorders

Interventions

Type	Name	Description
DRUG	Naltrexone for extended-release injectable suspension	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.
DRUG	Oral naltrexone	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.

Timeline

• Start date: 2017-09-21
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2016-12-01
• Last updated: 2020-06-16
• Results posted: 2020-06-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study