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

NCT01502644 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2017-07-11

Study results available
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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.

Conditions

Interventions

DRUG

Oxycodone

Daily dosage up to 120 mg

DRUG

Morphine

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

DRUG

Placebo

Placebo-matching oxycodone, placebo-matching morphine

Sponsors & Collaborators

  • Arthritis Foundation

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Ajay D Wasan, MD, MSc · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01502644 on ClinicalTrials.gov