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Trial record 1 of 1 for:    outcomes of opioid addicted prisoners with extended-release
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Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (OAPXRNTX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02617628
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Drug: extended release naltrexone Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (Vivitrol) Before vs. After Reentry
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Before Re-entry
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Drug: extended release naltrexone
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.
Other Name: Vivitrol

Active Comparator: After Re-entry
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Drug: extended release naltrexone
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.
Other Name: Vivitrol




Primary Outcome Measures :
  1. Proportion without relapse month 3 [ Time Frame: at month 3 ]
    relapsed to opiate use


Secondary Outcome Measures :
  1. weeks in treatment through month 6 [ Time Frame: at month 6 ]
    how long subject stays in treatment

  2. Rearrests [ Time Frame: 6 months, whole study ]
    time to rearrest

  3. quality of life (Euroqol) [ Time Frame: 6 months, whole duration of study ]
    Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression, scale of self-reported current health state



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617628


Locations
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United States, Pennsylvania
Center on the Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: George E Woody, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02617628    
Other Study ID Numbers: FC14-1409-21688
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Keywords provided by University of Pennsylvania:
opioid addiction
Additional relevant MeSH terms:
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Opioid-Related Disorders
Analgesics, Opioid
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents
Narcotic Antagonists