Effective Treatment for Prescription Opioid Abuse

Overview

There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2010

Detailed Description

There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents the poor retention and relapse that undermine many opioid detoxification regimens. Aim 2) Conduct a randomized, three-parallel-groups clinical trial (Study 2) to determine a duration of naltrexone therapy that sustains opioid abstinence following the buprenorphine detoxification.

Interventions

  • Drug: buprenorphine taper followed by naltrexone maintenance
    • direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial
  • Behavioral: Behavioral therapy

Arms, Groups and Cohorts

  • Experimental: 1-week buprenorphine taper
    • 1-week buprenorphine taper + behavioral therapy + urine toxicology
  • Experimental: 2-week buprenorphine taper
    • 2-week buprenorphine taper + behavioral therapy + urine toxicology
  • Experimental: 4-week buprenorphine taper
    • 4-week buprenorphine taper + behavioral therapy + urine toxicology

Clinical Trial Outcome Measures

Primary Measures

  • percentage of subjects abstinent from all opioids through the final day of detoxification
    • Time Frame: up to 12-week trial

Secondary Measures

  • percentage of subjects retained in treatment through the final day of detoxification
    • Time Frame: up to 12-week trial

Participating in This Clinical Trial

Inclusion Criteria

  • For inclusion in the proposed studies, subjects must be > 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification. Exclusion Criteria:

  • Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating. – Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Vermont Medical Center
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Stacey C. Sigmon, Ph.D., University of Vermont
  • Overall Official(s)
    • Stacey C. Sigmon, Ph.D., Principal Investigator, University of Vermont, Department of Psychiatry

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