Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-acting Injectable Naltrexone (Vivitrol).

Drug Dependence Clinical Trial

Official title: Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-acting Injectable Naltrexone (Vivitrol).

Status Withdrawn

Clinical Trial Summary

In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we will compare the efficacy of a primary care model of counseling (Condition 1) versus individualized cognitive-behavioral psychotherapy (Condition 2) for the treatment of opioid dependence. Treatment will last 12 weeks, and participants will be given 380mg of naltrexone per injection (3 injections in total; each lasting 4 weeks). Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment. Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction. Findings will elucidate whether injectable, long-acting naltrexone would be safe and effective in a primary care setting where medication would be administered in the absence of traditional cognitive-behavioral psychotherapy and indicate whether cognitive-behavioral psychotherapy adds to treatment effects above and beyond primary care counseling. If positive, this small controlled study will provide effect size estimates for a larger trial to assess Vivitrol ® in a primary care setting.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Dependence

• NCT number: NCT00675532
• Study type: Interventional
• Source: Yale University
• Status: Withdrawn
• Phase: N/A
• Start date: May 2011
• Completion date: August 2013