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

NCT05351333 | Active Not Recruiting DMC

• 2 other identifiers: 2022P0004861K23DA052041-01A1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalent Dose Conversion (MEDC)

  The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as main indicator for analgesic potency.

  6 days

Secondary Outcomes (22)

• Modified Brief Pain Inventory (BPI)

  6 days, 3 weeks, 6 weeks.

• Numerical Opioid Side Effects (NOSE)

  6 days

• PROMIS Pain Behavior

  6 days, 3 weeks, 6 weeks.

• PROMIS Pain Interference

  6 days, 3 weeks, 6 weeks.

• Patient Health Questionnaire 9 (PHQ-9)

  6 days, 3 weeks, 6 weeks.

Study Arms (2)

Conditioning Open-Label Placebo

EXPERIMENTAL

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.

Other: placebo

Treatment as usual

NO INTERVENTION

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.

Interventions

placebo OTHER

Sugar pill, with an essential-oil smell and of blue color used for conditioning.

Also known as: open-label placebo

Conditioning Open-Label Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (25)

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• Long-acting Opioids for Chronic Non-cancer Pain: A Review of the Clinical Efficacy and Safety [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Aug 27. Available from http://www.ncbi.nlm.nih.gov/books/NBK349988/

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• The Numerical Opioid Side Effect (NOSE) Assessment Tool. Journal of Cancer Pain & Symptom Palliation, 2005. 1(3): p. 3-6.

  RESULT

• Nielsen, S., et al., Comparing opioids: a guide to estimating oral morphine equivalents (OME) in research. National Drug and Alcohol Research Centre, University of NSW, 2014.

  RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Multiple Trauma; Burns; Agnosia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 28, 2022
• Study Start: August 3, 2022
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)