CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
Buprenorphine/naloxone +2 moredrug
Likely dose
Buprenorphine/naloxone 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/NCT01188421
NCT01188421Phase 2Completed
CompareCT.gov

Medications Development for Drug Abuse Disorders

Johns Hopkins University·interventional·Posted Aug 25, 2010·Updated Jul 6, 2017

In Brief

A Phase 2 clinical trial evaluating Buprenorphine/naloxone, Clonidine, and 1 other intervention for Opioid Related Disorders and 2 related conditions. Completed, enrolled 106 participants across 1 site.

Detailed Summary

This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants will be treated on a residential unit. The primary outcome measure is opioid withdrawal symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Related Disorders, Opioid Dependence, Opioid Addiction
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2010
Enrollment StartOct 1, 2010
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 15.9 years ago

Interventions

Buprenorphine/naloxonedrug

up to 8/2 mg Sublingual (SL) per day

Clonidinedrug

up to 0.8 mg per day (oral)

Tramadol ERdrug

up to 600 mg per day