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

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.

Conditions

• Opiate Addiction

Interventions

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Charles P O'Brien, MD, PhD · University of Pennsylvania

• James W Cornish, MD · University of Pennsylvania

• Donna Coviello, PhD · University of Pennsylvania

• Peter Friedmann, MD, MPH · Rhode Island Hospital

• Timothy Kinlock, PhD · Mountain Manor Treatment Center, Baltimore MD

• Edward B. Nunes, MD · New York State Psychiatric Institute, New York, NY

• Josh Lee, MD · New York University/Bellevue

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2015-08-31

Completion

2015-08-31

Countries

• United States

Study Locations