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Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (OAPXRNTX)

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
extended release naltrexone
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring opioid addiction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Opioid dependent with physiological features according to Diagnostic and Statistical Manual of Mental Disorders-5th edition
  • Interested in extended release naltrexone treatment
  • Eligible to have health benefits reinstated
  • Detoxified and able to pass a naloxone challenge (e.g. no withdrawal within 30 minutes after receiving 0.8 mg naloxone I.M. and documented by a score <5 on the Clinical Opiate Withdrawal Scale
  • Age 18 or above
  • Not being transferred to serve a longer sentence in a State or Federal prison
  • Provide their address or phone number along with the names and contact information of 3 or more persons likely to know where they can be reached with permission to contact them if unable to be reached in other ways
  • Able to speak and read English and provide informed consent
  • able to correctly answer 9 of 10 study quiz items
  • not pregnant and agree to the use of an acceptable form of birth control
  • can access to NET Steps via car or public or other transportation after reentry

Exclusion Criteria:

  • Planning to move from the Philadelphia area within the next 6 months
  • Neurological, cardiovascular, renal, hepatic (Alanine aminotransferase, Aspartate aminotransferase or Gamma-glutamyl transpeptidase >3 times top limit of normal) or another medical disorder that seriously impairs or makes hazardous ability to participate
  • Active tuberculosis
  • Currently psychotic, homicidal, suicidal
  • Uncontrolled seizure disorder
  • History of allergy to naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or any other components of the diluent
  • Chronic pain for which opioids are needed
  • Sentenced to naltrexone Treatment

Sites / Locations

  • Center on the Studies of Addiction

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Before Re-entry

After Re-entry

Arm Description

Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months

Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months

Outcomes

Primary Outcome Measures

Relapse to Opioid Use in Subjects by Month 3
Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.

Secondary Outcome Measures

Reincarceration
percentage of patients who were reincarcerated

Full Information

First Posted
November 23, 2015
Last Updated
January 12, 2021
Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02617628
Brief Title
Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
Acronym
OAPXRNTX
Official Title
Improving Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (Vivitrol) Before vs. After Reentry
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a collaboration between the University of Pennsylvania, the Philadelphia Prison System, and the North East Treatment Center (NETSteps). It purpose is to study the impact of an injectable opiate addiction medication (extended release naltrexone) given before reentry into the community that might help to improve reconnection to healthcare and other support systems, and possibly help reduce recidivism.
Detailed Description
The primary objectives for this study is to offer tools to support improve healthcare and related outcomes and reduce the risk of relapse and recidivism for opiate addicted prisoners reentering into the community after release from correctional facilities. In this study the investigators examine a medication-assisted therapy (extended release naltrexone) that is likely to be acceptable to correctional facilities and opioid addicted prisoners and that can improve the outcomes achieved by the usual detoxification/treatment referral approach. The results may be used to facilitate policy changes that involve adding extended release naltrexone to correctional facility formularies for use before reentry, and collaborating with one or more outpatient treatment providers to maintain continuity of care. Two hundred (200) opioid addicted prisoners currently incarcerated in the Philadelphia Prison System, who meet study admission criteria and express an interest in extended release naltrexone treatment, who give informed consent and will be scheduled for release within 14 days of being randomized into the study will be enrolled. These 200 subjects will be stratified by sex (male/females), will be 18 years or older, and are not sentenced).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
opioid addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Before Re-entry
Arm Type
Active Comparator
Arm Description
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Arm Title
After Re-entry
Arm Type
Active Comparator
Arm Description
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Intervention Type
Drug
Intervention Name(s)
extended release naltrexone
Other Intervention Name(s)
Vivitrol
Intervention Description
Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison, or either 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.
Primary Outcome Measure Information:
Title
Relapse to Opioid Use in Subjects by Month 3
Description
Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.
Time Frame
12 weeks (month 3)
Secondary Outcome Measure Information:
Title
Reincarceration
Description
percentage of patients who were reincarcerated
Time Frame
0 to 28 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Opioid dependent with physiological features according to Diagnostic and Statistical Manual of Mental Disorders-5th edition Interested in extended release naltrexone treatment Eligible to have health benefits reinstated Detoxified and able to pass a naloxone challenge (e.g. no withdrawal within 30 minutes after receiving 0.8 mg naloxone I.M. and documented by a score <5 on the Clinical Opiate Withdrawal Scale Age 18 or above Not being transferred to serve a longer sentence in a State or Federal prison Provide their address or phone number along with the names and contact information of 3 or more persons likely to know where they can be reached with permission to contact them if unable to be reached in other ways Able to speak and read English and provide informed consent able to correctly answer 9 of 10 study quiz items not pregnant and agree to the use of an acceptable form of birth control can access to NET Steps via car or public or other transportation after reentry Exclusion Criteria: Planning to move from the Philadelphia area within the next 6 months Neurological, cardiovascular, renal, hepatic (Alanine aminotransferase, Aspartate aminotransferase or Gamma-glutamyl transpeptidase >3 times top limit of normal) or another medical disorder that seriously impairs or makes hazardous ability to participate Active tuberculosis Currently psychotic, homicidal, suicidal Uncontrolled seizure disorder History of allergy to naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or any other components of the diluent Chronic pain for which opioids are needed Sentenced to naltrexone Treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George E Woody, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on the Studies of Addiction
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

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