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

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid; Morphine; Oxycodone

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.