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

Not Applicable

Withdrawn

• Conditions: Drug Dependence
• Interventions: Behavioral: Primary Care Counseling; Behavioral: Cognitive-behavioral psychotherapy

• Registration Number: NCT00675532
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-09
• Study Start: 2011-05
• Primary Completion: 2013-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-19
• Last Update Posted: 2013-07-22
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female individuals, ages 18 and above, meeting current diagnostic and statistical manual (DSM-IV) criteria for opioid dependence.
• Subject has voluntarily given informed consent and signed the informed consent document.
• Able to read English and complete study evaluations.

Exclusion Criteria

• Regular use of benzodiazepines.
• Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
• Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
• Abstinent from opiates for more than four weeks prior to naltrexone initiation.
• Medical problems that would preclude naltrexone treatment, such as laboratory evidence of significant hepato-cellular injury as evidenced by abnormal liver enzyme tests including SGOT and SGPT (> three times normal) or elevated bilirubin levels), and a history of cirrhosis.
• Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial evaluation for naltrexone, and every two weeks during the course of the study).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Primary Care Counseling	Primary Care Counseling
2	Cognitive-behavioral psychotherapy	Cognitive-behavioral psychotherapy (CBT)

Primary Outcome Measures

Name	Time	Method
Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction.	12 weeks

Trial Locations

Locations (1)

Yale New Haven Hospital Primary Care Center; 🇺🇸 New Haven, Connecticut, United States