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

NCT02824276 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2016P000725
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in Pain Sensitivity (Quantitative Sensory Testing)

  Pain Sensitivity will be assessed by Quantitative Sensory testing

  6 months

Study Arms (2)

Oral Opioid Medication

EXPERIMENTAL

The primary study medication will be oxycodone, with morphine sulfate immediate release (MSIR) as a backup in case of side effects

Drug: Oxycodone or morphine sulfate immediate release (MSIR)

Placebo Treatment

PLACEBO COMPARATOR

Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications

Drug: Placebo Treatment

Interventions

Placebo Treatment DRUG

Lactose (Appearance and Weight-matched placebo capsules)

Placebo Treatment

Oxycodone or morphine sulfate immediate release (MSIR) DRUG

Oxycodone or morphine sulfate immediate release (MSIR)

Also known as: Oral Opioid Medication

Oral Opioid Medication

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 25-65
• CLBP lasting for more than 6 months as the primary complaint
• typical pain ratings ≥ 4/10 on a visual analogue scale
• candidate for oral opioid therapy as assessed at the BWH Pain Management Center
• able to speak and understand English.

You may not qualify if:

• evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
• current (i.e., active) substance use disorder (SUD)
• past history of persistent opioid use (i.e., opioid use for more than 6 months) given that this could affect the biological systems of interest in the present study
• history of myocardial infarction or other serious cardiovascular condition
• current peripheral neuropathy
• current pregnancy, or intention to become pregnant during the study
• current intrathecal pump.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Oxycodone; Morphine

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Robert Edwards, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 6, 2016
• Study Start: January 6, 2017
• Primary Completion: December 30, 2022
• Study Completion: December 1, 2025
• Last Updated: February 4, 2026

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)