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Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opiate Dependence

Intervention: Behavioral: Buprenorphine/naloxone maintenance (Mtn) (Behavioral); Behavioral: Buprenorphine/naloxone detoxification (Dtx) (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
David A. Fiellin, MD, Principal Investigator, Affiliation: Yale University

Summary

The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use.

Clinical Details

Official title: Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

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

Primary outcome: Illicit opioid use

Secondary outcome:

Proportion of patients protectively transferred

Retention in treatment

Reduction in cocaine use

Reductions in HIV risk

Patient satisfaction

Health status

Utilization and costs of services

Detailed description: Prescription opioid dependence is increasing and creates a significant public health burden, but office-based physicians lack evidence-based guidelines to decide between maintenance or detoxification treatment with buprenorphine/naloxone. The proposed study compares buprenorphine/naloxone maintenance (Mtn) vs. detoxification (Dtx) in a 18-week randomized clinical trail in a heterogeneous population of prescription opioid dependent patients (N=120) in a primary care clinic. Patients are randomized to Mtn or Dtx after a 2-week induction period. Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, buprenorphine/naloxone will continue unchanged for the remainder of the study. In Dtx, the dosage of buprenorphine/naloxone will be tapered to zero over the next 3 weeks, and patients will not receive additional buprenorphine/naloxone for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup. The study will test the hypothesis that Mtn will lead to decreased illicit drug use and will demonstrate incremental cost-effectiveness compared to Dtx. Relevance to public health: The results of this study will help define the role of maintenance vs. detoxification with buprenorphine/naloxone in the care of prescription opioid dependent patients in primary care.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- opioid dependence

Exclusion Criteria:

- current dependence on alcohol, cocaine, benzodiazepines or sedatives

- current suicide or homicide risk

- current psychotic disorder or untreated major depression

- inability to read or understand English

- life-threatening or unstable medical problems

Locations and Contacts

The APT Foundation, Inc. -- Welch Building, New Haven, Connecticut 06519, United States

Yale University School of Medicine, New Haven, Connecticut 06520, United States

Additional Information

Starting date: July 2008
Last updated: July 19, 2013

Page last updated: August 23, 2015

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