Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
OAPXRNTX
Improving Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (Vivitrol) Before vs. After Reentry
1 other identifier
interventional
146
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
December 1, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
April 15, 2020
CompletedJanuary 28, 2021
January 1, 2021
3 years
November 23, 2015
February 11, 2020
January 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks (month 3)
Secondary Outcomes (1)
Reincarceration
0 to 28 months
Study Arms (2)
Before Re-entry
ACTIVE COMPARATORExtended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
After Re-entry
ACTIVE COMPARATORExtended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center on the Studies of Addiction
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Cadet T, Jalali A, Jeng PJ, Poole S, Woody G, Murphy SM. Determinants of health-related quality of life among individuals with opioid use disorder, recently released from incarceration. Addict Sci Clin Pract. 2023 May 25;18(1):34. doi: 10.1186/s13722-023-00375-0.
PMID: 37231479DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- W. Stuart Watson
- Organization
- University of Pennsylvania Office of Research Services
Study Officials
- PRINCIPAL INVESTIGATOR
George E Woody, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2015
First Posted
December 1, 2015
Study Start
January 1, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
January 28, 2021
Results First Posted
April 15, 2020
Record last verified: 2021-01