Long-acting naltrexone for pre-release prisoners: A randomized trial of mobile treatment

Principal Investigator: Michael S. Gordon, D.P.A.
Co-Investigator: Frank J. Vocci, Ph.D.
Co-Investigator: Terrence T. Fitzgerald, M.D. (Glenwood Life Counseling Center)
Funded By: National Institute on Drug Abuse
Grant #: 5R01DA040636
Total Project Period: 8/15/16 - 4/30/2021

This five-year NIH/NIDA funded study will focus on whether the addition of providing long-acting naltrexone (XR-NTX) treatment at a patients’ place of residence will increase adherence and thus efficacy of the medication. Project implementation will occur at seven prisons under the jurisdiction of the Maryland Department of Public Safety and Correctional Services (MDPSCS). Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient’s place of residence. All participants will be confirmed opiate-free by urine test and negative naloxone and oral naltrexone tests, and evaluated monthly for seven months and 12 months after release from prison. The proposed study has two specific aims: Aim1. To compare the two study conditions in terms of: a) XR-NTX treatment adherence; b) opioid use; c) criminal activity; d) re-arrest; e) re-incarceration; and f) HIV risk-behaviors (i. needle use; ii. risky sexual behaviors). Aim 2. To determine if the number of months of post-release XR-NTX treatment is related to outcome (a-f above), and if so, is there a point at which XR-NTX v. Non-XR-NTX equilibrates? This might help determine the number of injections, important because of XR-NTX cost. Many individuals in the criminal justice system drop out of treatment and therefore increasing ways to improve adherence by attempting to: 1) expand capacity; and 2) implement access by providing treatment at their place of residence may positively impact outcomes.