Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Intensive Rehabilitation

Completed · Phase 2 · Has a placebo group

Conditions studied: Spinal Cord Injuries, Polytrauma, Burn Injury, Pain Management

In brief

The use of conditioning open-label placebo (COLP) 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 dose to diminish adverse effects as well as the risk of addiction associated with narcotic treatment.

Key facts

Study ID

NCT03906721

Run by

Spaulding Rehabilitation Hospital

People needed

20

Starts

2019-02-20

Expected to finish

2021-11-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 5 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/or nociceptive pain (musculoskeletal or visceral) that is moderate or severe in nature (average VAS scale score of 4 or greater at time of enrollment),
• Respiratory and hemodynamically stable,
• With current narcotic use for pain control,
• Narcotic usage of no more than 120 mg of morphine equivalent

You may not qualify if…

• History of alcohol or drug dependence, as self-reported,
• A 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 dosage higher than 120 mg of morphine equivalent or 80 mg of a short-acting oxycodone,
• Current use of ventilator,
• Compromised medical status due to uncontrolled pathology such as cancer, heart failure, kidney or liver insufficiency, or any other condition which jeopardises patient's participation to the study
• Pregnancy or breastfeeding. Females in childbearing age who are eligible to participate in the study, will be tested for pregnancy by serum hCG test

Where it is running

• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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