NCT00781898

Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site

Prevention of Relapse to Opioid Addiction Using Depot Naltrexone

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.

Detailed description

This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol.

Conditions

• Opiate Addiction

Interventions

Type	Name	Description
DRUG	Depot naltrexone	Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
OTHER	Treatment as Usual (TAU)	Treatment as Usual (TAU) community treatment provided to the participant

Timeline

• Start date: 2008-06-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2008-10-29
• Last updated: 2017-10-23
• Results posted: 2017-10-23

Locations

1 site across 1 country: United States