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Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT03906721
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ross D. Zafonte, MD, Spaulding Rehabilitation Hospital

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 injuries. 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Drug: Placebo Drug: Oxycodone Other: Essential Oil Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Spinal Cord Injury Patients
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conditioning & Open-Label Placebo (COLP)
Days 1 to 5 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 6 to 10 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
Sugar pill used to condition patients.

Drug: Oxycodone
An opioid used for analgesia.
Other Name: Oxycodone Hydrochloride Tablets

Other: Essential Oil
An aromatic oil used for conditioning.

Control
For the duration of the study, days 1 to 10, oxycodone will be prescribed on a schedule of 3-4 times per day.
Drug: Oxycodone
An opioid used for analgesia.
Other Name: Oxycodone Hydrochloride Tablets




Primary Outcome Measures :
  1. Morphine Equivalent Dose Conversion (MEDC) [ Time Frame: 10 days ]
    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.


Secondary Outcome Measures :
  1. Modified Brief Pain Inventory (BPI) [ Time Frame: Day 1 and Day 10 ]
    The BPI is a short self-assessment questionnaire that provides information on various dimensions of pain including how pain developed, the types of pain a patient experiences, and time of day pain is experienced, as well as current ways of alleviating pain. The BPI also consists of the VAS Pain scale, a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring a patient' worst pain and least pain, on average and at present time. The Brief Pain Inventory provides information on the intensity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension).

  2. Spinal Cord Injury - Quality of Life measurement system (SCI-QOL) [ Time Frame: Day 1 and Day 10 ]
    This measurement system was developed to address the shortage of relevant and psychometrically sound patient reported outcome measures available for clinical care and research in spinal cord injury (SCI) rehabilitation. For the purpose of this research, the Pain Behavior subdomain will be the primary component of this scale to be used. This 7-item fixed-length scale measures manifestations of pain. These actions or reactions can be verbal or non-verbal and involuntary or deliberate. They include observable displays, and verbal reports of pain. This scale includes a small subset of the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Behavior item bank (i = 4) and three new items.

  3. Numerical Opioid Side Effects (NOSE) [ Time Frame: Day 1 and Day 10 ]
    Opioid therapy may be associated with adverse effects—which may affect the patient's perception of the overall satisfaction with opioid therapy. The Numerical Opioid Side Effect (NOSE) assessment tool is a simple, rapid, self-administered instrument which has the potential to be utilized in a busy pain clinic setting in efforts to document and longitudinally follow trends of opioid adverse effects.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 18 or older with traumatic and non-traumatic SCI (ASIA A-D),
  • SCI and pain of no more 5 years of evolution,
  • Who have; above, at, or sub-lesional neuropathic pain and/or nociceptive pain (musculoskeletal or visceral) that is moderate or severe in nature (average Visual Analogue Scale (VAS) score of 4 or greater at time of enrollment),
  • Respiratory and hemodynamically stable,
  • With or without current narcotic use for pain control,
  • Narcotic usage of no more than 75 mg of morphine equivalent

Exclusion Criteria:

  • 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 75 mg of morphine equivalent or 50 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 jeopardizes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906721


Contacts
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Contact: Leon Morales-Quezada, MD/PhD 617-952-6162 jmorales-quezada@partners.org

Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
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Principal Investigator: Ross D Zafonte, DO Spaulding Rehabilitation Hospital

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Responsible Party: Ross D. Zafonte, MD, Chair, Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03906721     History of Changes
Other Study ID Numbers: 2017P001673
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents