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Improving outcomes of opioid-addicted prisoners with extended release injectable naltrexone before reentry
Investigator (PI): Woody, George
Performing Organization (PO): (Current): University of Pennsylvania, Perelman School of Medicine, Department of Psychiatry / (215) 662-2818
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2020
Record Source/Award ID: PCORI/CER-1409-21688
Funding: Total Award Amount: $2,182,656
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: In 2014, PCORI, the FDA, CDC, ONDCP, and NIDA identified opioid abuse as a national problem. Jails and prisons, which serve as collection points for persons with these problems, typically provide detoxification, substance abuse education, counseling, support groups, and referral to treatment at reentry but rarely provide addiction treatment medication, and relapse is common. This situation differs from HIV, diabetes, and other disorders for which medication is prescribed in prison and at reentry for transition to continuing care. Methadone and buprenorphine are the most well-known treatment medications for opioid abuse, but few correctional facilities use them because they are narcotics and can be abused. Naltrexone is different; it is an antagonist with no abuse liability, is not sold or diverted, and does not cause withdrawal. An extended release injectable formulation (XR-NTX; Vivitrol[R]) blocks opioids for 30 days, and a dose before reentry will prevent relapse in the following weeks, thus giving the ex-prisoner protected time that is likely to reduce relapse and increase treatment participation. Conversations, a survey, and a focus group with ex-prisoners have shown that many of them are interested in trying it. Only one controlled study has been performed comparing XR-NTX before reentry with usual treatment. It was a pilot study in which 33 consenting prisoners were randomized to XR-NTX before reentry or usual treatment; 6 of 16 (38 percent) XR-NTX patients relapsed within two months versus 15 of 17 (88 percent) in usual treatment. We propose to follow up these findings in a collaboration with the Philadelphia Prison System (PPS) and NET Steps, a local program that provides addiction treatment in the PPS (NET@PPS) and that has worked with the Penn PI and staff. The design is to identify detoxified, consenting, opioid-addicted prisoners who are interested in XR-NTX. The first 200 individuals who meet study admission criteria will be randomized to receive XR-NTX before reentry with follow-up XR-NTX at NET Steps after reentry, or told to report to NET Steps after reentry for their first dose. Three additional XR-NTX doses will be offered, and prisoners who later change their minds will be eligible for other treatments but encouraged to complete all follow-ups. All participants will receive drug counseling and have a patient benefits manager to help restore benefits lost during incarceration. Urine drug tests will be performed weekly, and brief assessments will be conducted at months 1, 2, and 4, with more detailed assessments at months 3 and 6. PPS records will document arrests and incarcerations. The primary aim is proportion not relapsed by month 3. Secondary aims include quality of life; others are described in the protocol, as are dissemination plans. The long-term objective is to identify an intervention that correctional facilities will use and that prisoners will accept to improve their health and reduce the population burden of untreated opioid addiction.
MeSH Terms:
  • Community Integration
  • Humans
  • Mental Health Services /organization & administration
  • Naltrexone /*therapeutic use
  • Opioid-Related Disorders /*drug therapy
  • /*rehabilitation
  • Outcome Assessment, Health Care
  • Pennsylvania
  • Pilot Projects
  • Prisoners
  • Prisons
  • Quality of Life
  • Research Design
  • Time Factors
  • United States
  • Urinalysis
Country: United States
State: Pennsylvania
Zip Code: 19104
UI: 20153565
CTgovId: NCT02617628
Project Status: Completed
Record History: ('2019: Project extended to 2020. Start date corrected to 2016 per PCORI. \n2017: Project extended to 2019.',)