Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

Condition(s) targeted: Opiate Dependence

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

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Yale University

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

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

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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 (Bup). Although prior research has demonstrated the superiority of maintenance over detoxication for heroin dependent patients, the favorable clinical characteristics and improved treatment outcomes for prescription opioid dependent patients compared to heroin dependent patients and decreased severity of withdrawal symptoms with Bup have led many physicians to recommend detoxification with Bup for these patients. To provide data that could be used to develop evidence-based guidelines regarding detoxification or maintenance treatment for prescription opioid dependent patients, the proposed study compares Bup maintenance (Mtn) vs. detoxification (Dtx) in a 18-week randomized clinical trail of Bup 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, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup 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 in the care of prescription opioid dependent patients in primary care.

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

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

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

Starting date: July 2007
Ending date: April 2012
Last updated: January 15, 2008