MedTrace Logo

Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain

NCT02824276 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-02-04

No results posted yet for this study

Summary

Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of disability and reduced quality of life. The prescription of opioids for chronic low back pain (CLBP) has increased substantially within the past decade in the U.S. As noted by the CDC in their recent Guideline (released in March 2016): "Opioids are commonly prescribed for pain. An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or pain-related diagnoses (including acute and chronic pain) receive an opioid prescription. Interestingly, patients scoring very high on measures of psychological distress tend to be systematically excluded from RCTs, even though this subgroup of patients is highly prevalent within the chronic pain population.

This study will provide key information on individual differences in the outcomes of opioid treatment, and its findings should facilitate more effective tailoring of analgesic regimens to individual patient characteristic.

Conditions

  • Low Back Pain

Interventions

DRUG

Oxycodone or morphine sulfate immediate release (MSIR)

Oxycodone or morphine sulfate immediate release (MSIR)

DRUG

Placebo Treatment

Lactose (Appearance and Weight-matched placebo capsules)

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Robert Edwards, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2022-12-30
Completion
2025-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02824276 on ClinicalTrials.gov