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

• ClinicalTrials.gov Identifier: NCT02824276
• Recruitment Status: Unknown
• First Posted: July 6, 2016
• Last Update Posted: July 6, 2017
• Sponsor: Brigham and Women's Hospital
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Robert Edwards, Brigham and Women's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Drug: Oxycodone or morphine sulfate immediate release (MSIR); Drug: Placebo Treatment	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
• Actual Study Start Date: January 6, 2017
• Estimated Primary Completion Date: September 30, 2019
• Estimated Study Completion Date: September 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oral Opioid Medication; 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); Oxycodone or morphine sulfate immediate release (MSIR); Other Name: Oral Opioid Medication
Placebo Comparator: Placebo Treatment; Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications	Drug: Placebo Treatment; Lactose (Appearance and Weight-matched placebo capsules)

Outcome Measures

Primary Outcome Measures :

1. Changes in Pain Sensitivity (Quantitative Sensory Testing) [ Time Frame: 6 months ]
   Pain Sensitivity will be assessed by Quantitative Sensory testing

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Marise Cornelius; 617-732-9463; mcornelius@partners.org

Locations

United States, Massachusetts

Brigham and Women's Hospital; Recruiting

Boston, Massachusetts, United States, 02467

Contact: Robert Edwards, PhD

Sponsors and Collaborators

Brigham and Women's Hospital

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Robert Edwards, PhD; Brigham and Women's Hospital

More Information

• Responsible Party: Robert Edwards, Associate Professor of Anesthesia, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02824276
• Other Study ID Numbers: 2016P000725
• First Posted: July 6, 2016
• Last Update Posted: July 6, 2017
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Analgesics, Opioid; Morphine; Oxycodone; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents