Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/26/2019 |
| Start Date: | January 1, 2016 |
| End Date: | December 31, 2018 |
Improving Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (Vivitrol) Before vs. After Reentry
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.
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.
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).
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).
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
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