CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 188 enrolled
Drug / intervention
Suboxone (SCH 000484) +1 moredrug
Likely dose
Suboxone (SCH 000484) 2 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/NCT00604188
NCT00604188Phase 4Completed
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A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users

Merck Sharp & Dohme LLC·interventional·Posted Jan 30, 2008·Updated Jul 2, 2017

In Brief

A Phase 4 clinical trial evaluating Suboxone (SCH 000484) and Subutex (SCH 028444) for Opiate Dependence and 2 related conditions. Completed, enrolled 188 participants.

Detailed Summary

The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to Suboxone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpiate Dependence, Drug Dependence, Substance Dependence
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2008
Enrollment StartFeb 22, 2008
Primary CompletionDec 10, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.4 years ago

Interventions

Suboxone (SCH 000484)drug

2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride and Naloxone. Daily dosage of 8 mg - 24 mg. Duration: 28 Days

Subutex (SCH 028444)drug

2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride. Daily dosage of 8 mg - 24 mg. Duration: 28 Days