Long-acting Naltrexone for Pre-release Prisoners
Primary Purpose
Opiate Addiction
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
XR-NTX
place of residence
opioid treatment program
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Addiction
Eligibility Criteria
Inclusion Criteria:
- Adult male or female inmate at MTC, BPRU, JPRU, BCCC, or MCIW and be eligible for release within 30 days
- History of opiate disorder [meeting DSM-V criteria of dependence at the time of incarceration]
- Suitability for XR-NTX treatment as determined by medical evaluation
- Currently opioid-free by history, with negative urine for all opioids and no signs of opiate withdrawal
- Willingness to enroll in XR-NTX treatment in prison [not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release]
- Planning to live in Baltimore City or County.
- Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration
Exclusion Criteria:
- Liver function test levels greater than three times normal
- Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease). Adequately treated medical conditions are acceptable
- Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania). Adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed
- History of allergic reaction to XR-NTX
- Current chronic pain diagnosis for which opioids are prescribed
- Creatinine above normal limits
- Pregnancy (for women)
- Breast-feeding (for women)
- Suicidal ideation (within the past 6-months)
- Body Mass Index (BMI) > 40
- Unadjudicated charges that may result in transfer to another facility and/or additional prison time.
Sites / Locations
- Maryland Department of Public Safety and Correctional ServicesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vivitrol at place of residence
Vivitrol at opioid treatment program
Arm Description
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
One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at a community opioid treatment program.
Outcomes
Primary Outcome Measures
treatment adherence
XR-NTX+ MMTx vs. XR-NTX-OTx following release from prison
Any illicit opioid used
defined as continuous counts of days and urine toxicologies for heroin or other illicit opioid
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
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
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
Injection drug use and HIV sexual risk factors
Injection drug use and HIV sexual risk factors will be measured using the Risk Assessment Battery.
Secondary Outcome Measures
Treatment Group Equilibration
time point at which the trajectories for use in the two treatment groups cross
Full Information
NCT ID
NCT02867124
First Posted
August 8, 2016
Last Updated
February 17, 2023
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02867124
Brief Title
Long-acting Naltrexone for Pre-release Prisoners
Official Title
Long-acting Naltrexone for Pre-release Prisoners: A Randomized Trial of Mobile Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vivitrol at place of residence
Arm Type
Experimental
Arm Description
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
Arm Title
Vivitrol at opioid treatment program
Arm Type
Active Comparator
Arm Description
One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at a community opioid treatment program.
Intervention Type
Drug
Intervention Name(s)
XR-NTX
Other Intervention Name(s)
long-acting naltrexone
Intervention Description
Vivitrol
Intervention Type
Other
Intervention Name(s)
place of residence
Other Intervention Name(s)
residence
Intervention Description
One injection of XR-NTX in prison, followed by 6 monthly injections post-release at place of residence
Intervention Type
Other
Intervention Name(s)
opioid treatment program
Other Intervention Name(s)
OTP
Intervention Description
One injection of XR-NTX in prison, followed by 6 monthly injections post-release at a community opioid treatment program
Primary Outcome Measure Information:
Title
treatment adherence
Description
XR-NTX+ MMTx vs. XR-NTX-OTx following release from prison
Time Frame
six months
Title
Any illicit opioid used
Description
defined as continuous counts of days and urine toxicologies for heroin or other illicit opioid
Time Frame
1,2,3,4,5,6,7 and 12-months following release from prison
Title
re-arrest
Description
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
Time Frame
12-months following release from prison
Title
re-incarceration
Description
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
Time Frame
12-months following release from prison
Title
criminal activity
Description
Self-reported crime days will be defined as continuous counts of days collected from the Addiction Severity Index and Time Line Follow-Back
Time Frame
1,2,3,4,5,6,7 and 12-months following release from prison
Title
Injection drug use and HIV sexual risk factors
Description
Injection drug use and HIV sexual risk factors will be measured using the Risk Assessment Battery.
Time Frame
6 and 12-months following release from prison
Secondary Outcome Measure Information:
Title
Treatment Group Equilibration
Description
time point at which the trajectories for use in the two treatment groups cross
Time Frame
6 and 12-months following release from prison
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult male or female inmate at MTC, BPRU, JPRU, BCCC, or MCIW and be eligible for release within 30 days
History of opiate disorder [meeting DSM-V criteria of dependence at the time of incarceration]
Suitability for XR-NTX treatment as determined by medical evaluation
Currently opioid-free by history, with negative urine for all opioids and no signs of opiate withdrawal
Willingness to enroll in XR-NTX treatment in prison [not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release]
Planning to live in Baltimore City or County.
Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration
Exclusion Criteria:
Liver function test levels greater than three times normal
Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease). Adequately treated medical conditions are acceptable
Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania). Adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed
History of allergic reaction to XR-NTX
Current chronic pain diagnosis for which opioids are prescribed
Creatinine above normal limits
Pregnancy (for women)
Breast-feeding (for women)
Suicidal ideation (within the past 6-months)
Body Mass Index (BMI) > 40
Unadjudicated charges that may result in transfer to another facility and/or additional prison time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael S Gordon, DPA
Phone
410-837-3977
Ext
251
Email
mgordon@friendsresearch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Gordon, DPA
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryland Department of Public Safety and Correctional Services
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Davis-Hart
Ext
251
Email
sandra.davis-hart@maryland.gov
12. IPD Sharing Statement
Citations:
PubMed Identifier
28011389
Citation
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.
Results Reference
derived
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Long-acting Naltrexone for Pre-release Prisoners
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