Using open-label placebo to manage opioid use in patients with spinal cord injuries, polytrauma, and burns
Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation
This study is testing if a special type of placebo treatment can help people with spinal cord injuries, multiple injuries, and burns use less opioids while still managing their pain effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Charlestown, Massachusetts) |
| Trial ID | NCT05351333 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a conditioning open-label placebo (COLP) approach to reduce opioid dosage in patients suffering from spinal cord injuries, polytrauma, and burn injuries. Participants will be randomly assigned to receive either the COLP treatment or standard opioid care, with assessments conducted to measure pain relief, side effects, and overall treatment satisfaction. The study aims to maintain pain management while minimizing the risks associated with opioid use, such as addiction and adverse side effects. Various assessment tools will be utilized to evaluate pain levels, medication changes, and psychological factors throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with spinal cord injuries, polytrauma, or burn injuries who are currently using narcotics for pain management.
Not a fit: Patients with pain conditions not related to spinal cord injuries, polytrauma, or burns, or those who are not currently using narcotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid consumption while still providing effective pain relief for patients.
How similar studies have performed: While the use of open-label placebos is a novel approach in this context, similar studies have shown promise in other areas of pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 18 or older with traumatic and non-traumatic SCI (ASIA A-D), polytrauma, or burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital, * SCI, polytrauma, or burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital and pain of no more than five years of evolution, * Patients admitted to the Spaulding Comprehensive Rehabilitation Unit at Spaulding Rehabilitation Hospital, * Who have; above, at, or sub-lesional neuropathic pain and nociceptive pain (musculoskeletal or visceral) that is moderate or severe (average VAS scale score of 4 or greater at time of enrollment), * Inpatients with polytrauma (defined as having injuries that affect two or more body systems or organs) or patients with burn injuries, amputations, or post-surgical (e.g., orthopedic surgery) * Respiratory and hemodynamically stable, * With current narcotic use for pain control, * Narcotic usage of no more than 120 mg of morphine equivalent Exclusion Criteria: * History of alcohol or drug dependence, as self-reported, * History of bipolar disorder or psychosis, as self-reported, * Any substantial decrease in alertness, language reception, or attention that might interfere with understanding, * Current usage of narcotic medication with a dosage higher than 120 mg of morphine equivalent or 80 mg of short-acting oxycodone, or 30 mg of hydromorphone * Current use of a ventilator, * Compromised medical status due to uncontrolled pathologies such as cancer, heart failure, kidney or liver insufficiency, or any other condition which jeopardizes the patient's participation in the study * Pregnancy or breastfeeding. Participants with pregnancy capability will be tested for pregnancy by serum human chorionic gonadotropin (hCG) test.
Where this trial is running
Charlestown, Massachusetts
- Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Leon Morales-Quezada, MD, MPH, PhD
- Email: jmorales-quezada@mgh.harvard.edu
- Phone: 617-952-6162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.