CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,269 enrolled
Drug / intervention
Buprenorphine/naloxone +1 moredrug
Likely dose
Buprenorphine/naloxone 16 mgfrom 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/NCT00315341
NCT00315341Phase 4Completed
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Starting Treatment With Agonist Replacement Therapies (START)

University of California, Los Angeles·interventional·Posted Apr 18, 2006·Updated Jan 6, 2017

In Brief

A Phase 4 clinical trial evaluating Buprenorphine/naloxone and Methadone for Opiate-related Disorders. Completed, enrolled 1,269 participants across 9 sites.

Detailed Summary

The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpiate-related Disorders
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2006
Enrollment StartApr 1, 2006
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.2 years ago

Interventions

Buprenorphine/naloxonedrug

Participants receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need.

Methadonedrug

Participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit.