Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Morphine Milligram Equivalents (MME)
研究概览
简要总结
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.
详细描述
The investigators will conduct an assessor blind controlled clinical trial, participants in the COLP group will be fully informed about the interventions the participants will be allocated for. As this study is designed to be a proof-of-concept, only an authorized member of the study staff will be conducting the assessments. Suppose the subject has been approved to participate by the treating physician. In that case, the co-investigator will discuss the study's details and answer questions both before and during the first study visit.
Study Design and Flow:
This study contains one experimental arm and one control group. The experiment will run in a parallel design, with each subject having six days of participation. Each group will have evaluations before starting the trial (Baseline) and assessments after the six days of study participation. Subjects will be evaluated using the following tools: Morphine Equivalent Dose Conversion (MEDC); Modified Brief Pain Inventory (BPI); Spinal Cord Injury - Quality of Life measurement system (SCI-QOL); and Numerical Opioid Side Effects (NOSE). The investigators will also record medication changes, side effects, and pain levels as measured by the Visual Analog Scale (VAS) daily for each patient.
For this open placebo- opioid dose reduction study. The investigators will enroll a total of 60 subjects with SCI, polytrauma, and burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital and ongoing neuropathic or nociceptive pain. Experimental treatments will take place at either Spaulding Rehabilitation Hospital (SRH). The investigators will coordinate with the appropriate care outlets to ensure that the study's procedures will not interfere with their standard of care at Spaulding. This includes, but is not limited to: physicians, therapists, and nurses working with the patient. The investigators will schedule inpatients as their clinical schedule allows.
After enrollment, subjects will be randomized to receive COLP treatment or to receive standardized opioid dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 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
排除标准
- •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
研究组 & 干预措施
Conditioning & Open-Label Placebo (COLP)
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.
干预措施: Oxycodone (Drug)
Treatment-as-usual
For the duration of the study, days 1 to 6, oxycodone will be prescribed on a schedule of 3-4 times per day.
干预措施: Oxycodone (Drug)
Conditioning & Open-Label Placebo (COLP)
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.
干预措施: Placebo (Drug)
Conditioning & Open-Label Placebo (COLP)
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.
干预措施: Essential Oil (Other)
结局指标
主要结局
Morphine Milligram Equivalents (MME)
时间窗: 6 days
Morphine Milligram Equivalents (MME) are used to standardize opioid exposure by expressing the analgesic potency of different opioids relative to morphine. MME is calculated by multiplying the prescribed opioid dose by the daily frequency of administration and then by an opioid-specific conversion factor. The resulting value is expressed as milligrams of morphine equivalents (mg MME). Values range from 0 mg MME upward, with higher values indicating greater opioid exposure, which has been associated with an increased risk of adverse clinical outcomes.
次要结局
- Visual Analog Scale for Pain (VAS)(Day 6)
- Spinal Cord Injury - Quality of Life Measurement System (SCI-QOL)(Day 1 and Day 6)
- Numerical Opioid Side Effects (NOSE)(Change in NOSE score from Day 1 and Day 6)
- Electroencephalography - Power Spectrum(Power spectrum Change from Day 1 to Day 6)
- Near-infrared Spectroscopy (NIRS)(Day 1 and Day 6)
- Metabolomics Assessment(Day 1 and Day 6. This outcome measure data represents the change in metabolite concentration from Day 1 (baseline) to Day 6(post-intervention))
研究者
Jorge Leon Morales-Quezada, MD, PhD
Research Faculty, Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital