CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 113 enrolled
Drug / intervention
Behavioral: Buprenorphine/naloxone maintenance (Mtn) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00555425
NCT00555425Phase 4Completed

Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

Yale University·interventional·Posted Nov 8, 2007·Updated Jan 14, 2019

In Brief

A Phase 4 clinical trial evaluating Behavioral: Buprenorphine/naloxone maintenance (Mtn) and Behavioral: Buprenorphine/naloxone detoxification (Dtx) for Opiate Dependence. Completed, enrolled 113 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 8, 2007
Enrollment StartJul 1, 2008
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 18.7 years ago

Interventions

Behavioral: Buprenorphine/naloxone maintenance (Mtn)behavioral

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.

Behavioral: Buprenorphine/naloxone detoxification (Dtx)behavioral

Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. 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.