CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Oxycodone +2 moredrug
Likely dose
Oxycodone 120 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/NCT01502644
NCT01502644Phase 4Completed
CompareCT.gov

Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

Brigham and Women's Hospital·interventional·Posted Jan 2, 2012·Updated Jul 11, 2017

In Brief

A Phase 4 clinical trial evaluating Oxycodone, Morphine, and 1 other intervention for Chronic Low Back Pain and 3 related conditions. Completed, enrolled 81 participants across 1 site.

Detailed Summary

Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative affect \[NA\]). The purpose of the study is to determine whether CLBP patients with either a high vs. a low or moderate degree of NA have different pain relief responses to oral opioids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain, Degenerative Disc Disease, Depression, Anxiety
CountriesUnited States
CollaboratorsArthritis Foundation, National Institute on Drug Abuse (NIDA)

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2, 2012
Enrollment StartFeb 1, 2009
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.5 years ago

Interventions

Oxycodonedrug

Daily dosage up to 120 mg

Morphinedrug

Daily dosage up to 90 mg immediate release or 180 mg extended release

Placebodrug

Placebo-matching oxycodone, placebo-matching morphine