ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-03
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05351333

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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,
  2. * 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,
  3. * Patients admitted to the Spaulding Comprehensive Rehabilitation Unit at Spaulding Rehabilitation Hospital,
  4. * 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),
  5. * 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)
  6. * Respiratory and hemodynamically stable,
  7. * With current narcotic use for pain control,
  8. * Narcotic usage of no more than 120 mg of morphine equivalent
  1. * History of alcohol or drug dependence, as self-reported,
  2. * History of bipolar disorder or psychosis, as self-reported,
  3. * Any substantial decrease in alertness, language reception, or attention that might interfere with understanding,
  4. * 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
  5. * Current use of a ventilator,
  6. * 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
  7. * Pregnancy or breastfeeding. Participants with pregnancy capability will be tested for pregnancy by serum human chorionic gonadotropin (hCG) test.

Contacts and Locations

Study Locations (Sites)

Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-03
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2022-08-03
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • open-label placebo
  • Spinal cord injury (SCI)
  • opioid
  • pain management
  • addiction prevention
  • pharmaco-behavioral
  • rehabilitation
  • in-patients

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Polytrauma
  • Burns