Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation
Key facts
- Who runs it
- Spaulding Rehabilitation Hospital
- Where
- Charlestown, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 66 people, planned
- Started
- 3 Aug 2022
- Ended
- 31 Jul 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- placebo
- Record updated
- 27 October 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- History of alcohol or drug dependence, as self-reported,
- History of bipolar disorder or psychosis, as self-reported,
- 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
- Any substantial decrease in alertness, language reception, or attention that might interfere with understanding,
- Current use of a ventilator,
Where in United States
- Spaulding Rehabilitation HospitalCharlestown, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Conditioning Open-Label PlaceboTreatment being tested
Days 1 to 3 will include the acquisition phase where the opioid medication will be prescribed on a schedule of 3-4 times per day and paired with an open-label placebo. Day 4 and 6 will be the evoked phase, and patients will receive only the open-label placebo pill. On day 5 the opioid medication will be re-introduced as pharmacological reinforcement.
Treatment: placebo
- Treatment as usualNo study treatment, for comparison
Patients in the standard of care group will receive their analgesic treatment through Spaulding Pharmacy as prescribed by their treating physicians. The treatment regime will include an opioid medication at the standard recommended dosage. Participants in this group will receive the treatment orally for 6 consecutive days.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 27 October 2025