Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Morphine Equivalent Dose Conversion (MEDC)
研究概览
简要总结
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.
详细描述
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Morphine Equivalent Dose Conversion (MEDC)
时间窗: 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.
次要结局
- Metabolite assessment of Indole-3-Lactic acid(6 days)
- Metabolite assessment of Indole-3-Propionic acid(6 days)
- Metabolite assessment of Indole-3-Acetic acid(6 days)
- Functional near-infrared spectroscopy (fNIRS)(6 days)
- Metabolite assessment of Tyrosine(6 days)
- Metabolite assessment of Total indoxyl sulfate(6 days)
- Modified Brief Pain Inventory (BPI)(6 days, 3 weeks, 6 weeks.)
- Patient Health Questionnaire 9 (PHQ-9)(6 days, 3 weeks, 6 weeks.)
- Generalized Anxiety Disorder questionnaire 7 (GAD-7)(6 days, 3 weeks, 6 weeks.)
- Metabolite assessment of 3-Methyl Xanthine(6 days)
- TSQM-9(6 days)
- Quantitative electroencephalography (qEEG)(6 days)
- Qualitative Exit Interview(1 day)
- Metabolite assessment of Serotonin(6 days)
- Metabolite assessment of Uric acid(6 days)
- Pain Pressure Threshold (PPT)(6 days)
- Numerical Opioid Side Effects (NOSE)(6 days)
- TEX-Q(6 days)
- Metabolite assessment of Tryptophan(6 days)
- PROMIS Pain Behavior(6 days, 3 weeks, 6 weeks.)
- PROMIS Pain Interference(6 days, 3 weeks, 6 weeks.)
- Metabolite assessment of Kynurenine(6 days)
研究者
Jorge Leon Morales-Quezada, MD, PhD
Principal Investigator
Spaulding Rehabilitation Hospital