Status:
ACTIVE_NOT_RECRUITING
Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation
Lead Sponsor:
Spaulding Rehabilitation Hospital
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Spinal Cord Injuries
Polytrauma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The use of the conditioning open-label placebo (COLP) paradigm will be studied as a dose extension method to lower opioid dosage in patients with spinal cord injury, polytrauma, and burn injury. The g...
Detailed Description
The study is a randomized controlled trial (RCT) parallel-group, assessor blind with one experimental arm, the conditioning open-label placebo (COLP), and one control group following the regular regim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05351333
Start Date
August 3 2022
End Date
July 31 2026
Last Update
October 27 2025
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129