CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19 enrolled
Drug / intervention
Methadone +1 moredrug
Likely dose
Methadone 60 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/NCT01559454
NCT01559454Phase 4Completed
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A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Treatment in Opioid Dependent Chronic Back Pain Patients

State University of New York at Buffalo·interventional·Posted Mar 21, 2012·Updated Nov 3, 2020

In Brief

A Phase 4 clinical trial evaluating Methadone and Buprenorphine/naloxone for Low Back Pain. Completed, enrolled 19 participants across 1 site.

Detailed Summary

Chronic pain patients are treated with prescription opioids and many exhibit opioid addiction. Currently, there are no evidence-based guidelines to better manage patients with chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and methadone treatment in these patients. The investigators hypothesize that both buprenorphine and methadone treatment will reduce pain and addiction behaviors and increase functioning in these patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 21, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.3 years ago

Interventions

Methadonedrug

10-60 mg/day divided by 2-4 times a day for 6 months

Buprenorphine/naloxonedrug

4-16 mg/day divided by 2-4 times a day for 6 months