Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury

NCT03906721 | Completed Phase 2 FDA Drug

• 1 other identifier: 2017P001673
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries; Polytrauma; Burn Injury

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 the main indicator for analgesic potency. For drug utilization, there is a need to present usage data consistently, considering dosing requirements. One method of representing opioid use at the population level is through the application of Defined Daily Doses (DDD), however, this represents a problem partly because opioids require highly individualized dosing and need to be titrated to pain response, rather than having standard therapeutic dose ranges. Oral morphine equivalents are based on the idea that different doses of different opioids may give a similar analgesic effect. Where the doses of two different opioids are considered to give a comparable analgesic effect, they are deemed to be equianalgesic doses.

  6 days

Secondary Outcomes (6)

• Modified Brief Pain Inventory (BPI)

  Day 1 and Day 6

• Spinal Cord Injury - Quality of Life measurement system (SCI-QOL)

  Day 1 and Day 6

• Numerical Opioid Side Effects (NOSE)

  Day 1 and Day 6

• Electroencephalography

  Day 1 and Day 6

• Near-infrared spectroscopy (NIRS)

  Day 1 and Day 6

Study Arms (2)

Conditioning & Open-Label Placebo (COLP)

EXPERIMENTAL

Days 1 to 3 will include the acquisition phase where oxycodone will be prescribed on a schedule of 3-4 times per day and paired with open-placebo and smelling the essential oil. Days 4 to 6 will be the evoked phase, and patients will receive full oxycodone dosage on alternating days with open placebo and smelling the essential oil.

Drug: Placebo; Drug: Oxycodone; Other: Essential Oil

Treatment-as-usual

OTHER

For the duration of the study, days 1 to 6, oxycodone will be prescribed on a schedule of 3-4 times per day.

Drug: Oxycodone

Interventions

Placebo DRUG

Sugar pill used to condition patients.

Conditioning & Open-Label Placebo (COLP)

Oxycodone DRUG

An opioid used for analgesia.

Also known as: Oxycodone Hydrochloride Tablets

Conditioning & Open-Label Placebo (COLP); Treatment-as-usual

Essential Oil OTHER

An aromatic oil used for conditioning.

Conditioning & Open-Label Placebo (COLP)

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 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Multiple Trauma; Burns

Interventions

Oxycodone; Oils, Volatile

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Oils; Lipids

Study Officials

• Ross D Zafonte, DO

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Physical Medicine and Rehabilitation

Model Details: This is a randomized single-blind open-label placebo clinical trial. 60 inpatients will be included from SRH, both men and women aged 18 or older with traumatic and non-traumatic SCI (ASIA A-D), polytrauma and burn injury patients from the Comprehensive Rehabilitation Program 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). All subjects must meet clinical criteria for the use of opioids as a treatment for pain management.

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 8, 2019
• Study Start: February 20, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)