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

Primary Purpose

Spinal Cord Injuries, Polytrauma, Burns

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
placebo
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Arm Label

Conditioning Open-Label Placebo

Treatment as usual

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Modified Brief Pain Inventory (BPI)
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. Worst Pain Score: 1 - 4 = Mild Pain Worst Pain Score: 5 - 6 = Moderate Pain Worst Pain Score: 7 - 10 = Severe Pain
Numerical Opioid Side Effects (NOSE)
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. Each item is 0 to 10, zero being no side effects (better outcome) and 10 worst outcome.
PROMIS Pain Behavior
The PROMIS Pain Behavior item banks measure self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain. These actions or reactions can be verbal or nonverbal, and involuntary or deliberate.
PROMIS Pain Interference
The PROMIS Pain Interference item banks assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The pain interference short forms are universal rather than disease specific. All assess pain interference over the past seven days
Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 components of the longer Patient Health Questionnaire offer psychologists concise, self-administered tools for assessing depression. They incorporate the Diagnostic and Statistical Manual 4th Edition (DSM-IV) depression criteria with other leading major depressive symptoms into a brief self-report instruments that are commonly used for screening and diagnosis, as well as selecting and monitoring treatment.
Generalized Anxiety Disorder questionnaire 7 (GAD-7)
The Generalized Anxiety Disorder 7 (GAD-7) is a 7-item instrument used to briefly measure or assess one of the most common mental disorders.
TEX-Q
TEX-Q, a scale for generically and multidimensionally measuring expectations of medical or psychological treatments. Its fully generic nature enables the comparability of assessments across different treatments and conditions.
TSQM-9
The TSQM is a 14-item psychometrically robust and validated instrument consisting of four scales.The four scales of the TSQM include the effectiveness scale, the side effects scale, the convenience scale, and the global satisfaction scale.
Quantitative electroencephalography (qEEG)
stands out as a valuable, non-invasive tool because it provides reliable and relevant information about brain functioning during rest, sensory stimulation and cognitive tasks. In addition, this technique is safe, low-cost, and employs an easy methodology, thus making it an appropriate tool for use in clinical practice. qEEG at rest and during pain processing event-related potentials (ERP's) at the patient's bed side. The qEEG and ERP's recordings will be processed for analytical purposes, standard EEG metrics will be explored (e.g. spectral analysis, connectivity, source localization), while ERP's will provide information related to pain and values of valence and arousal.
Functional near-infrared spectroscopy (fNIRS)
This method is based on near-infrared light absorption fluctuations that depend on concentration changes of the chromophores O2Hb and HHb in the tissue under investigation. We will use it to investigate cerebral metabolism of oxygenated (O2Hb), deoxygenated (HHb) and total hemoglobin (tHb) during pain processing ERP's. Changes in tHb, defined as the sum of the changes in O2Hb and HHb, can be used as a measure of blood volume changes. fNIRS can provide the equivalent of cortical blood-oxygen-level-dependent (BOLD) signal, like functional magnetic resonance imaging (fMRI).
Qualitative Exit Interview
The main purpose of the exit interview is to explore individual experiences to describe how patients with pain conceive the effects of the experimental interventions (COLP/TAU).
Metabolite assessment of 3-Methyl Xanthine
Serum level of metabolite in (ng/mL).
Metabolite assessment of Serotonin
Serum level of metabolite in (ng/mL).
Metabolite assessment of Uric acid
Serum level of metabolite in (ug/mL).
Metabolite assessment of Tyrosine
Serum level of metabolite in (ug/mL).
Metabolite assessment of Kynurenine
Serum level of metabolite in (ng/mL).
Metabolite assessment of Indole-3-Lactic acid
Serum level of metabolite in (ng/mL).
Metabolite assessment of Indole-3-Propionic acid
Serum level of metabolite in (ng/mL).
Metabolite assessment of Indole-3-Acetic acid
Serum level of metabolite in (ng/mL).
Metabolite assessment of Tryptophan
Serum level of metabolite in (ug/mL).
Metabolite assessment of Total indoxyl sulfate
Serum level of metabolite in (ug/mL).
Pain Pressure Threshold (PPT)
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation [19]. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle. PPT has been used on a wide variety of patients and conditions, including musculoskeletal and neuromuscular disorders (e.g., Parkinson disease, tension headaches, pelvic pain, low back pain, myofascial trigger points, knee osteoarthritis, shoulder pain). PPT is a quick, objective measure used to quantify pain intensity

Full Information

First Posted
April 8, 2022
Last Updated
October 25, 2022
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05351333
Brief Title
Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation
Official Title
Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study is a randomized controlled trial (RCT) parallel-group, assessor blind with one experimental arm, the conditioning open-label placebo (COLP), and one control group following the regular regimen, treatment as usual (TAU). Tools for assessment: Morphine Equivalent Dose Conversion (MEDC); Pain Pressure Threshold (PPT); Modified Brief Pain Inventory (BPI); PROMIS Pain-Related Measures (PROMIS); Numerical Opioid Side Effects (NOSE); Treatment satisfaction questionnaire for medication (TSQM) and Treatment expectation questionnaire (TEX-Q); Measurements of anxiety, depression - Generalized Anxiety Disorder 7 (GAD7) and Patient Health Questionnaire-9 (PHQ9). Recording of medication changes and side effects. Reported visual analog scale (VAS) for pain assessed by the nursing team and recorded at the electronic medical record (EMR); finally, the qualitative exit interview. Neurophysiological and metabolomic phenotyping, using the following measures, Quantitative electroencephalography (qEEG) for quantitative assessment (EEG), functional near-infrared spectroscopy (fNIRS), and metabolomics assessment. Following enrollment, subjects will be randomized to receive COLP treatment or a standard of care opioid dosage. The study team will perform baseline assessments, and subjects in the COLP group will undergo three consecutive days of prescribed - as needed - pro re nata (PRN) opioid 100% dose + opioid conditioning paired with taste and odorous placebos (pill and smell). Afterward, subjects will receive a 50% dose + COLP for three days. The nursing team will alternate the active opioid medication with total placebo dosages to decrease the therapeutic opioid dose by 50%. Voluntary COLP continuation: After the participants have completed the experimental intervention (day 6), all outcomes have been collected (pre and post-measurements). Patients randomized to the COLP group will be asked to continue the COLP intervention during hospitalization if the participant agrees to continue using COLP. We will re-evaluate the following variables: MEDC, PPT, BPI, PROMIS pain, TSQM, and NOSE once COLP is discontinued (e.g., in case of increased pain and opioid utilization or if the patient is being discharged and transferred to another facility). For subjects allocated in the control group (treatment-as-usual), the customary treatment routine will follow the standard of care for patients suffering from mild to moderate pain, including all pharmacological agents (NSAIDs, narcotics, and combos) used for pain management. The study team will record total narcotic dosages at the beginning and end of the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Polytrauma, Burns
Keywords
open-label placebo, Spinal cord injury (SCI), opioid, pain management, addiction prevention, pharmaco-behavioral, rehabilitation, in-patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conditioning Open-Label Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
open-label placebo
Intervention Description
Sugar pill, with an essential-oil smell and of blue color used for conditioning.
Primary Outcome Measure Information:
Title
Morphine Equivalent Dose Conversion (MEDC)
Description
The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as main indicator for analgesic potency.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Modified Brief Pain Inventory (BPI)
Description
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. Worst Pain Score: 1 - 4 = Mild Pain Worst Pain Score: 5 - 6 = Moderate Pain Worst Pain Score: 7 - 10 = Severe Pain
Time Frame
6 days, 3 weeks, 6 weeks.
Title
Numerical Opioid Side Effects (NOSE)
Description
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. Each item is 0 to 10, zero being no side effects (better outcome) and 10 worst outcome.
Time Frame
6 days
Title
PROMIS Pain Behavior
Description
The PROMIS Pain Behavior item banks measure self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain. These actions or reactions can be verbal or nonverbal, and involuntary or deliberate.
Time Frame
6 days, 3 weeks, 6 weeks.
Title
PROMIS Pain Interference
Description
The PROMIS Pain Interference item banks assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The pain interference short forms are universal rather than disease specific. All assess pain interference over the past seven days
Time Frame
6 days, 3 weeks, 6 weeks.
Title
Patient Health Questionnaire 9 (PHQ-9)
Description
The PHQ-9 components of the longer Patient Health Questionnaire offer psychologists concise, self-administered tools for assessing depression. They incorporate the Diagnostic and Statistical Manual 4th Edition (DSM-IV) depression criteria with other leading major depressive symptoms into a brief self-report instruments that are commonly used for screening and diagnosis, as well as selecting and monitoring treatment.
Time Frame
6 days, 3 weeks, 6 weeks.
Title
Generalized Anxiety Disorder questionnaire 7 (GAD-7)
Description
The Generalized Anxiety Disorder 7 (GAD-7) is a 7-item instrument used to briefly measure or assess one of the most common mental disorders.
Time Frame
6 days, 3 weeks, 6 weeks.
Title
TEX-Q
Description
TEX-Q, a scale for generically and multidimensionally measuring expectations of medical or psychological treatments. Its fully generic nature enables the comparability of assessments across different treatments and conditions.
Time Frame
6 days
Title
TSQM-9
Description
The TSQM is a 14-item psychometrically robust and validated instrument consisting of four scales.The four scales of the TSQM include the effectiveness scale, the side effects scale, the convenience scale, and the global satisfaction scale.
Time Frame
6 days
Title
Quantitative electroencephalography (qEEG)
Description
stands out as a valuable, non-invasive tool because it provides reliable and relevant information about brain functioning during rest, sensory stimulation and cognitive tasks. In addition, this technique is safe, low-cost, and employs an easy methodology, thus making it an appropriate tool for use in clinical practice. qEEG at rest and during pain processing event-related potentials (ERP's) at the patient's bed side. The qEEG and ERP's recordings will be processed for analytical purposes, standard EEG metrics will be explored (e.g. spectral analysis, connectivity, source localization), while ERP's will provide information related to pain and values of valence and arousal.
Time Frame
6 days
Title
Functional near-infrared spectroscopy (fNIRS)
Description
This method is based on near-infrared light absorption fluctuations that depend on concentration changes of the chromophores O2Hb and HHb in the tissue under investigation. We will use it to investigate cerebral metabolism of oxygenated (O2Hb), deoxygenated (HHb) and total hemoglobin (tHb) during pain processing ERP's. Changes in tHb, defined as the sum of the changes in O2Hb and HHb, can be used as a measure of blood volume changes. fNIRS can provide the equivalent of cortical blood-oxygen-level-dependent (BOLD) signal, like functional magnetic resonance imaging (fMRI).
Time Frame
6 days
Title
Qualitative Exit Interview
Description
The main purpose of the exit interview is to explore individual experiences to describe how patients with pain conceive the effects of the experimental interventions (COLP/TAU).
Time Frame
1 day
Title
Metabolite assessment of 3-Methyl Xanthine
Description
Serum level of metabolite in (ng/mL).
Time Frame
6 days
Title
Metabolite assessment of Serotonin
Description
Serum level of metabolite in (ng/mL).
Time Frame
6 days
Title
Metabolite assessment of Uric acid
Description
Serum level of metabolite in (ug/mL).
Time Frame
6 days
Title
Metabolite assessment of Tyrosine
Description
Serum level of metabolite in (ug/mL).
Time Frame
6 days
Title
Metabolite assessment of Kynurenine
Description
Serum level of metabolite in (ng/mL).
Time Frame
6 days
Title
Metabolite assessment of Indole-3-Lactic acid
Description
Serum level of metabolite in (ng/mL).
Time Frame
6 days
Title
Metabolite assessment of Indole-3-Propionic acid
Description
Serum level of metabolite in (ng/mL).
Time Frame
6 days
Title
Metabolite assessment of Indole-3-Acetic acid
Description
Serum level of metabolite in (ng/mL).
Time Frame
6 days
Title
Metabolite assessment of Tryptophan
Description
Serum level of metabolite in (ug/mL).
Time Frame
6 days
Title
Metabolite assessment of Total indoxyl sulfate
Description
Serum level of metabolite in (ug/mL).
Time Frame
6 days
Title
Pain Pressure Threshold (PPT)
Description
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation [19]. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle. PPT has been used on a wide variety of patients and conditions, including musculoskeletal and neuromuscular disorders (e.g., Parkinson disease, tension headaches, pelvic pain, low back pain, myofascial trigger points, knee osteoarthritis, shoulder pain). PPT is a quick, objective measure used to quantify pain intensity
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leon Morales-Quezada, MD, MPH, PhD
Phone
617-952-6162
Email
jmorales-quezada@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ines Mesia-Toledo, MD
Phone
6179526926
Email
imesiatoledo@mgh.harvard.edu
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leon Morales-Quezada, MD, MPH, PhD
Phone
617-952-6162
Email
jmorales-quezada@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

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