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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA040636 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.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.
Disorders involving opioid use are a severe problem among jail and prison inmates. Inmates in the US, Canada, Australia, and many European and Asian nations have disproportionately higher rates of opioid use disorders than their general populations. Scarce resources are provided for corrections-based substance use treatment in many nations, and many inmates with OUDs remain untreated. The use of long-acting, injectable naltrexone (XR-NTX) may be a promising form of treatment for pre-release prisoners. Naltrexone blocks the intoxicating and reinforcing effects of opioids, but has no opioid-like effects. This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication. Project implementation will occur at five pre-release prisons under the jurisdiction of the Maryland Department of Public Safety and Correctional Services (MDPSCS): 1) Metropolitan Transition Center (MTC) for men; 2) Baltimore Pre-Release Unit (BPRU) for men; 3) Jessup Pre-Release Unit (JPRU) for men; 4) Baltimore City Correctional Center (BCCC) and 5) Maryland Correctional Institution (MCI) for Women. 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 would 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivitrol at place of residence | Experimental | One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at the participants's place of residence utilizing mobile medical treatment |
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| Vivitrol at opioid treatment program | Active Comparator | One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at a community opioid treatment program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XR-NTX | Drug | Vivitrol |
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| Measure | Description | Time Frame |
|---|---|---|
| treatment adherence | XR-NTX+ MMTx vs. XR-NTX-OTx following release from prison | six months |
| Any illicit opioid used | defined as continuous counts of days and urine toxicologies for heroin or other illicit opioid | 1,2,3,4,5,6,7 and 12-months following release from prison |
| re-arrest | Re-arrest will be assessed using self-report on the Arrests and Days Incarcerated form and from Official Records received from the Maryland Department of Public Safety and Correctional Services | 12-months following release from prison |
| re-incarceration | Re-incarceration will be assessed using self-report on the Arrests and Days Incarcerated form and from Official Records received from the Maryland Department of Public Safety and Correctional Services | 12-months following release from prison |
| criminal activity | Self-reported crime days will be defined as continuous counts of days collected from the Addiction Severity Index and Time Line Follow-Back | 1,2,3,4,5,6,7 and 12-months following release from prison |
| Injection drug use and HIV sexual risk factors | Injection drug use and HIV sexual risk factors will be measured using the Risk Assessment Battery. | 6 and 12-months following release from prison |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Group Equilibration | time point at which the trajectories for use in the two treatment groups cross | 6 and 12-months following release from prison |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Gordon, DPA | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Department of Public Safety and Correctional Services | Towson | Maryland | 21286 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40342086 | Derived | Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3. | |
| 28011389 | Derived | Gordon MS, Vocci FJ, Fitzgerald TT, O'Grady KE, O'Brien CP. Extended-release naltrexone for pre-release prisoners: A randomized trial of medical mobile treatment. Contemp Clin Trials. 2017 Feb;53:130-136. doi: 10.1016/j.cct.2016.12.015. Epub 2016 Dec 20. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2018 | Mar 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012111 | Residence Characteristics |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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| place of residence | Other | One injection of XR-NTX in prison, followed by 6 monthly injections post-release at place of residence |
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| opioid treatment program | Other | One injection of XR-NTX in prison, followed by 6 monthly injections post-release at a community opioid treatment program |
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| D004778 |
| Environment and Public Health |