Phase 3
Completed N=146
Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
Opiate Dependence
Source: ClinicalTrials.gov NCT02617628 ↗
Enrolled (actual)
146
Serious AEs
15.8%
Results posted
Apr 2020
Primary outcomePrimary: Relapse to Opioid Use in Subjects by Month 3 — 16; 20 Participants — p=0.38
◆ Published Evidence
Not yet cited
0citations
Determinants of health-related quality of life among individuals with opioid use disorder, recently released from incarceration.
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.
Linked Publications
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Determinants of health-related quality of life among individuals with opioid use disorder, recently released from incarceration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse to Opioid Use in Subjects by Month 3 |
16; 20 | 0.38 |
| SECONDARY Reincarceration |
28; 22 | 0.01 sig |
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 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
Data sourced from ClinicalTrials.gov (NCT02617628) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.