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

NCT ID: NCT02824276

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-06
• Study Completion Date: 2025-12-01

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.

Detailed Description

Changes in pain sensitivity will be examined (i.e., OIH) among subgroups of CLBP patients prescribed oral opioid therapy.

Investigators will conduct a moderate-term, double-blind, randomized controlled trial, and use quantitative sensory testing (QST) to evaluate whether changes in pain sensitivity and pain modulation occur as a result of long-term opioid use. Investigators hypothesize that increases in pain sensitivity (i.e., OIH) and maladaptive changes in endogenous pain modulation (i.e., enhanced temporal summation of pain) will occur as a result of long-term opioid use, but that these changes will be observed predominantly among patients with high levels of negative affect and pain-related catastrophizing.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oral Opioid Medication

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

Group Type: EXPERIMENTAL

Oxycodone or morphine sulfate immediate release (MSIR)

Intervention Type: DRUG

Oxycodone or morphine sulfate immediate release (MSIR)

Placebo Treatment

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

Group Type: PLACEBO_COMPARATOR

Placebo Treatment

Intervention Type: DRUG

Lactose (Appearance and Weight-matched placebo capsules)

Interventions

Oxycodone or morphine sulfate immediate release (MSIR)

Oxycodone or morphine sulfate immediate release (MSIR)

Intervention Type: DRUG

Placebo Treatment

Lactose (Appearance and Weight-matched placebo capsules)

Intervention Type: DRUG

Other Intervention Names

Oral Opioid Medication

Eligibility Criteria

Inclusion Criteria

1. age 25-65

2. CLBP lasting for more than 6 months as the primary complaint

3. typical pain ratings ≥ 4/10 on a visual analogue scale

4. candidate for oral opioid therapy as assessed at the BWH Pain Management Center

5. able to speak and understand English.

Exclusion Criteria

1. evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures

2. current (i.e., active) substance use disorder (SUD)

3. 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

4. history of myocardial infarction or other serious cardiovascular condition

5. current peripheral neuropathy

6. current pregnancy, or intention to become pregnant during the study

7. current intrathecal pump.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Robert Edwards

Associate Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Edwards, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2016P000725

Identifier Type: -

Identifier Source: org_study_id