Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

Description

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 goal is to provide the same level of pain relief with a reduced opioid intake to diminish side effects as well as the risk of addiction associated with opioid treatment.

Conditions

Spinal Cord Injuries, Polytrauma, Burns

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Study Overview

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Study Details

Study overview

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 goal is to provide the same level of pain relief with a reduced opioid intake to diminish side effects as well as the risk of addiction associated with opioid treatment.

Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Charlestown

Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, United States, 02129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Spaulding Rehabilitation Hospital,

Study Record Dates

2026-07-31