Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
CompletedPhase 1NCT02824276
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
- Conditions
- Interventions
- Drug: Oxycodone or morphine sulfate immediate release (MSIR)
- Drug: Placebo Treatment
- Sponsor
- Brigham and Women's Hospital
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Start date
- 2017-01-06
- Primary completion
- 2022-12-30
- Sex
- All
- Age range
- from 25 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02824276