Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

Yale University

Status and phase: Completed; Phase 4

Conditions: Opiate Dependence

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00555425

1R01DA020576-01A1 (U.S. NIH Grant/Contract)

0504027597

R01DA020576 (U.S. NIH Grant/Contract)

DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

1

Active Comparator group

Description:

Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.

Treatment:

Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn)

2

Experimental group

Description:

Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn 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 Buprenorphine/naloxone.

Treatment:

Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)