Spinal Cord InjuriesNCT05351333
Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation
A study of Spinal Cord Injuries and Polytrauma, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Polytrauma, Burns
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Polytrauma, Burns
- Being tested
- placebo
- Keywords
- open-label placebo, Spinal cord injury (SCI), opioid, pain management, addiction prevention, pharmaco-behavioral, rehabilitation, in-patients
- Medical subject headings
- Spinal Cord Injuries, Multiple Trauma, Burns, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Also called open-label placebo
Sugar pill, with an essential-oil smell and of blue color used for conditioning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days
Secondary outcomes (22)
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
Measured: 6 days, 3 weeks, 6 weeks.
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.
Measured: 6 days
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.
Measured: 6 days, 3 weeks, 6 weeks.
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
Measured: 6 days, 3 weeks, 6 weeks.
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.
Measured: 6 days, 3 weeks, 6 weeks.
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.
Measured: 6 days, 3 weeks, 6 weeks.
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.
Measured: 6 days
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.
Measured: 6 days
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.
Measured: 6 days
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).
Measured: 6 days
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).
Measured: 1 day
Metabolite assessment of 3-Methyl Xanthine
Serum level of metabolite in (ng/mL).
Measured: 6 days
Metabolite assessment of Serotonin
Serum level of metabolite in (ng/mL).
Measured: 6 days
Metabolite assessment of Uric acid
Serum level of metabolite in (ug/mL).
Measured: 6 days
Metabolite assessment of Tyrosine
Serum level of metabolite in (ug/mL).
Measured: 6 days
Metabolite assessment of Kynurenine
Serum level of metabolite in (ng/mL).
Measured: 6 days
Metabolite assessment of Indole-3-Lactic acid
Serum level of metabolite in (ng/mL).
Measured: 6 days
Metabolite assessment of Indole-3-Propionic acid
Serum level of metabolite in (ng/mL).
Measured: 6 days
Metabolite assessment of Indole-3-Acetic acid
Serum level of metabolite in (ng/mL).
Measured: 6 days
Metabolite assessment of Tryptophan
Serum level of metabolite in (ug/mL).
Measured: 6 days
Metabolite assessment of Total indoxyl sulfate
Serum level of metabolite in (ug/mL).
Measured: 6 days
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
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start3 Aug 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jorge Leon Morales-Quezada, MD, PhD, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351333
- Sponsor's protocol ID
- 2022P000486
- Other IDs
- 1K23DA052041-01A1
- Status last verified
- Oct 2025
- First submitted
- 8 Apr 2022
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/
PubMed 22553896McCance-Katz EF. The Substance Abuse and Mental Health Services Administration (SAMHSA): New Directions. Psychiatr Serv. 2018 Oct 1;69(10):1046-1048. doi: 10.1176/appi.ps.201800281. Epub 2018 Aug 13. No abstract available.
PubMed 30099944Cardenas DD, Bryce TN, Shem K, Richards JS, Elhefni H. Gender and minority differences in the pain experience of people with spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1774-81. doi: 10.1016/j.apmr.2004.04.027.
PubMed 15520972Kaptchuk TJ, Miller FG. Placebo Effects in Medicine. N Engl J Med. 2015 Jul 2;373(1):8-9. doi: 10.1056/NEJMp1504023. No abstract available.
PubMed 26132938Martin WR, Eades CG, Thompson WO, Thompson JA, Flanary HG. Morphine physical dependence in the dog. J Pharmacol Exp Ther. 1974 Jun;189(3):759-71. No abstract available.
PubMed 4858404Colloca L, Tinazzi M, Recchia S, Le Pera D, Fiaschi A, Benedetti F, Valeriani M. Learning potentiates neurophysiological and behavioral placebo analgesic responses. Pain. 2008 Oct 15;139(2):306-314. doi: 10.1016/j.pain.2008.04.021. Epub 2008 Jun 6.
PubMed 18538928Doering BK, Rief W. Utilizing placebo mechanisms for dose reduction in pharmacotherapy. Trends Pharmacol Sci. 2012 Mar;33(3):165-72. doi: 10.1016/j.tips.2011.12.001. Epub 2012 Jan 25.
PubMed 22284159Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol. 2008;59:565-90. doi: 10.1146/annurev.psych.59.113006.095941.
PubMed 17550344Pearce JM. The placebo enigma. QJM. 1995 Mar;88(3):215-20. No abstract available.
PubMed 7767672Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.
PubMed 21203519Le Bars D, Gozariu M, Cadden SW. Animal models of nociception. Pharmacol Rev. 2001 Dec;53(4):597-652.
PubMed 11734620Giang DW, Goodman AD, Schiffer RB, Mattson DH, Petrie M, Cohen N, Ader R. Conditioning of cyclophosphamide-induced leukopenia in humans. J Neuropsychiatry Clin Neurosci. 1996 Spring;8(2):194-201. doi: 10.1176/jnp.8.2.194.
PubMed 9081556Ader R, Mercurio MG, Walton J, James D, Davis M, Ojha V, Kimball AB, Fiorentino D. Conditioned pharmacotherapeutic effects: a preliminary study. Psychosom Med. 2010 Feb;72(2):192-7. doi: 10.1097/PSY.0b013e3181cbd38b. Epub 2009 Dec 22.
PubMed 20028830Sandler AD, Glesne CE, Bodfish JW. Conditioned placebo dose reduction: a new treatment in attention-deficit hyperactivity disorder? J Dev Behav Pediatr. 2010 Jun;31(5):369-75. doi: 10.1097/DBP.0b013e3181e121ed.
PubMed 20495473Perlis M, Grandner M, Zee J, Bremer E, Whinnery J, Barilla H, Andalia P, Gehrman P, Morales K, Thase M, Bootzin R, Ader R. Durability of treatment response to zolpidem with three different maintenance regimens: a preliminary study. Sleep Med. 2015 Sep;16(9):1160-8. doi: 10.1016/j.sleep.2015.06.015. Epub 2015 Jul 7.
PubMed 26298795
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT05351333
- Acronym / sponsor ID
- 2022P000486
- Conditions
- Spinal Cord Injuries, Polytrauma, Burns
- Keywords
- open-label placebo, Spinal cord injury (SCI), opioid, pain management, addiction prevention, pharmaco-behavioral, rehabilitation, in-patients
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conditioning Open-Label Placebo | Experimental | Other: placeboDays 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: open-label placeboSugar pill, with an essential-oil smell and of blue color used for conditioning. | Other | Conditioning Open-Label Placebo |
Primary outcome
Morphine Equivalent Dose Conversion (MEDC)
Time frame: 6 days
The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as main indicator for analgesic potency.
22 secondary outcomes
Modified Brief Pain Inventory (BPI)
Time frame: 6 days, 3 weeks, 6 weeks.
Numerical Opioid Side Effects (NOSE)
Time frame: 6 days
PROMIS Pain Behavior
Time frame: 6 days, 3 weeks, 6 weeks.
PROMIS Pain Interference
Time frame: 6 days, 3 weeks, 6 weeks.
Patient Health Questionnaire 9 (PHQ-9)
Time frame: 6 days, 3 weeks, 6 weeks.
Generalized Anxiety Disorder questionnaire 7 (GAD-7)
Time frame: 6 days, 3 weeks, 6 weeks.
TEX-Q
Time frame: 6 days
TSQM-9
Time frame: 6 days
Quantitative electroencephalography (qEEG)
Time frame: 6 days
Functional near-infrared spectroscopy (fNIRS)
Time frame: 6 days
Qualitative Exit Interview
Time frame: 1 day
Metabolite assessment of 3-Methyl Xanthine
Time frame: 6 days
Metabolite assessment of Serotonin
Time frame: 6 days
Metabolite assessment of Uric acid
Time frame: 6 days
Metabolite assessment of Tyrosine
Time frame: 6 days
Metabolite assessment of Kynurenine
Time frame: 6 days
Metabolite assessment of Indole-3-Lactic acid
Time frame: 6 days
Metabolite assessment of Indole-3-Propionic acid
Time frame: 6 days
Metabolite assessment of Indole-3-Acetic acid
Time frame: 6 days
Metabolite assessment of Tryptophan
Time frame: 6 days
Metabolite assessment of Total indoxyl sulfate
Time frame: 6 days
Pain Pressure Threshold (PPT)
Time frame: 6 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Results publication: PubMed 22553896Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/
- Results publication: PubMed 30099944McCance-Katz EF. The Substance Abuse and Mental Health Services Administration (SAMHSA): New Directions. Psychiatr Serv. 2018 Oct 1;69(10):1046-1048. doi: 10.1176/appi.ps.201800281. Epub 2018 Aug 13. No abstract available.
- Results publication: PubMed 15520972Cardenas DD, Bryce TN, Shem K, Richards JS, Elhefni H. Gender and minority differences in the pain experience of people with spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1774-81. doi: 10.1016/j.apmr.2004.04.027.
- Results publication: PubMed 26132938Kaptchuk TJ, Miller FG. Placebo Effects in Medicine. N Engl J Med. 2015 Jul 2;373(1):8-9. doi: 10.1056/NEJMp1504023. No abstract available.
- Results publication: PubMed 4858404Martin WR, Eades CG, Thompson WO, Thompson JA, Flanary HG. Morphine physical dependence in the dog. J Pharmacol Exp Ther. 1974 Jun;189(3):759-71. No abstract available.
- Results publication: PubMed 18538928Colloca L, Tinazzi M, Recchia S, Le Pera D, Fiaschi A, Benedetti F, Valeriani M. Learning potentiates neurophysiological and behavioral placebo analgesic responses. Pain. 2008 Oct 15;139(2):306-314. doi: 10.1016/j.pain.2008.04.021. Epub 2008 Jun 6.
- Results publication: PubMed 22284159Doering BK, Rief W. Utilizing placebo mechanisms for dose reduction in pharmacotherapy. Trends Pharmacol Sci. 2012 Mar;33(3):165-72. doi: 10.1016/j.tips.2011.12.001. Epub 2012 Jan 25.
- Results publication: PubMed 17550344Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol. 2008;59:565-90. doi: 10.1146/annurev.psych.59.113006.095941.
- Results publication: PubMed 7767672Pearce JM. The placebo enigma. QJM. 1995 Mar;88(3):215-20. No abstract available.
- Results publication: PubMed 21203519Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.
- Results publication: PubMed 11734620Le Bars D, Gozariu M, Cadden SW. Animal models of nociception. Pharmacol Rev. 2001 Dec;53(4):597-652.
- Results publication: PubMed 9081556Giang DW, Goodman AD, Schiffer RB, Mattson DH, Petrie M, Cohen N, Ader R. Conditioning of cyclophosphamide-induced leukopenia in humans. J Neuropsychiatry Clin Neurosci. 1996 Spring;8(2):194-201. doi: 10.1176/jnp.8.2.194.
- Individual participant dataSharing planned: No
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Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Spinal Cord Injuries and Polytrauma, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Equivalent Dose Conversion (MEDC) (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351333, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.