NCT01502644

Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative affect \[NA\]). The purpose of the study is to determine whether CLBP patients with either a high vs. a low or moderate degree of NA have different pain relief responses to oral opioids.

Detailed description

The level of high, moderate or low NA was determined based on the participant's score on the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-reported questionnaire that has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each item on the questionnaire is scored from 0 (least amount of anxiety/depression) to 3 (greatest amount of anxiety/depression), with total score between 0 and 21 for either anxiety or depression. Participants were assigned to high, moderate or low NA groups using the following HADS score criteria: * High NA = HADS score ≥9 on each subscale * Moderate NA = HADS score ≥6 to ≤8 on each subscale * Low NA = HADS score ≤5 on each subscale

Conditions

• Chronic Low Back Pain
• Degenerative Disc Disease
• Depression
• Anxiety

Interventions

Type	Name	Description
DRUG	Oxycodone	Daily dosage up to 120 mg
DRUG	Morphine	Daily dosage up to 90 mg immediate release or 180 mg extended release
DRUG	Placebo	Placebo-matching oxycodone, placebo-matching morphine

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-01-02
• Last updated: 2017-07-11
• Results posted: 2017-06-08

Locations

1 site across 1 country: United States