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

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.

Conditions

• Drug Dependence

Interventions

BEHAVIORAL

Primary Care Counseling

Subjects in this condition will attend bi-weekly 15 minute sessions with the study nurse for primary care counseling which is a brief manual-guided, medically focused counseling approach to the treatment of opioid dependent individuals seen in primary care settings. The brief counseling sessions involve repeated support for and monitoring of medication compliance, and the provision of advice regarding established methods for coping with psychological and social factors that lead to drug use.

BEHAVIORAL

Cognitive-behavioral psychotherapy

Subjects in the CBT condition will participate in bi-weekly 50-minute-long individualized cognitive-behavioral psychotherapy sessions with a CBT trained clinician. The general purpose of the therapy is to: (1) acquire information about important concepts and aspects of recovery from opioid addiction; (2) increase self-awareness of specific problems and issues in relation to addiction and recovery, and (3) learn new coping skills to deal with problems contributing to or resulting from the addiction and to improve overall psychosocial functioning. The primary focus of this approach is to provide patients with frequent supportive contact and to teach cognitive-behavioral relapse prevention skills.

Sponsors & Collaborators

• Yale University

  lead OTHER

Principal Investigators

• David Fiellin, Ph.D. · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2013-05-31

Completion

2013-08-31

Countries

• United States

Study Locations