Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

Completed · Phase 2/Phase 3

Conditions studied: Opiate Dependence

In brief

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.

Key facts

Study ID

NCT02617628

Run by

University of Pennsylvania

People needed

146

Starts

2016-01-01

Expected to finish

2018-12-31

Last updated by the study team

2021-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Center on the Studies of Addiction — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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