Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

NCT ID: NCT02617628

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2018-12-31

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).

Conditions

Opiate Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Before Re-entry

Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months

Group Type: ACTIVE_COMPARATOR

extended release naltrexone

Intervention Type: DRUG

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.

After Re-entry

Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months

Group Type: ACTIVE_COMPARATOR

extended release naltrexone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Vivitrol

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George E Woody, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Center on the Studies of Addiction

Philadelphia, Pennsylvania, United States

Countries

United States

References

Cadet T, Jalali A, Jeng PJ, Poole S, Woody G, Murphy SM. Determinants of health-related quality of life among individuals with opioid use disorder, recently released from incarceration. Addict Sci Clin Pract. 2023 May 25;18(1):34. doi: 10.1186/s13722-023-00375-0.

Reference Type: DERIVED

PMID: 37231479 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FC14-1409-21688

Identifier Type: -

Identifier Source: org_study_id