Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

Study Overview
=================
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).

Official Title
-----------------
Improving Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (Vivitrol) Before vs. After Reentry

Conditions
-----------------
Opiate Dependence

Intervention / Treatment
-----------------
* Drug: extended release naltrexone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Before Re-entry<br>Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months | Drug: extended release naltrexone<br>* 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.<br>* Other names: Vivitrol;|
| Active Comparator: After Re-entry<br>Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months | Drug: extended release naltrexone<br>* 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.<br>* Other names: Vivitrol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reincarceration | percentage of patients who were reincarcerated | 0 to 28 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid addiction