CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 53 enrolled
Drug / intervention
Tramadol +1 moredrug
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/NCT00980044
NCT00980044Phase 3Completed
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Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Michelle Lofwall·interventional·Posted Sep 18, 2009·Updated Apr 5, 2017

In Brief

A Phase 3 clinical trial evaluating Tramadol and Placebo for Substance Withdrawal Syndrome. Completed, enrolled 53 participants across 1 site.

Detailed Summary

Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubstance Withdrawal Syndrome
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2009
Enrollment StartOct 1, 2009
Primary CompletionFeb 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.8 years ago

Interventions

Tramadoldrug

Oral Medication

Placebodrug

Oral Medication