Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation
Spinal Cord Injuries, Polytrauma, Burns
About this trial
This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring open-label placebo, Spinal cord injury (SCI), opioid, pain management, addiction prevention, pharmaco-behavioral, rehabilitation, in-patients
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
- 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.
Sites / Locations
- Spaulding Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Conditioning Open-Label Placebo
Treatment as usual
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.
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.