Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

January 1, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Opiate Dependence
Interventions
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.

Trial Locations (1)

19104

Center on the Studies of Addiction, Philadelphia

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

University of Pennsylvania

OTHER

NCT02617628 - Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone | Biotech Hunter | Biotech Hunter