Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Differences across drugs in Withdrawal relief assessed by Pain and Craving Index (PCI).
研究概览
简要总结
This study is designed to track brain functional changes in individuals with i) chronic back pain + opioid use (CBP+O) and individuals with ii) chronic back pain + opioid misuse disorder (CBP+mOUD) following a brief drug delay and re-exposure manipulation. Re-exposure could be placebo, the participant's own opioid dose, or a dopaminergic treatment (DA+NSAID). The participants will be also evaluated for changes in cognition, emotion, and motor abilities with opioid delay and re-exposure to placebo, opioid, or DA+NSAID.
详细描述
Screening Visit (2-3 hours) (if applicable):
Participants that have participated in Project 1 Aim 1 within three months of consenting to Project 1 Aim 2 will not require a screening visit and can continue on to Visit 1, 2 and 3 of Aim 2.
A screening visit will be applicable for those participants that did not participate in Project 1 Aim 1, and for those that had participated but did so more than three months prior to consenting to Project 1 Aim 2.
Participants will be evaluated with inclusion/exclusion criteria and complete the informed consent. A medical/pain history will be taken and a physical exam will be completed by a physician. Participants will complete a number of questionnaires assessing health and medical history, past and current pain levels, and personality. Participants will have their blood drawn to confirm appropriate kidney and liver function (investigators will take ~40mL of blood). Participants will also be asked to provide a urine sample to confirm if any illicit drugs are in their system.
Participants will also be instructed to report their pain and craving ratings via an application that will be downloaded on their device. They will need to complete two ratings per day that they are involved in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
All data analysis personnel are masked regarding groupings
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
- •History of low back pain for a minimum of 6 months daily (prior to screening), meeting the Quebec Task Force Classification System symptom categories I-III;
- •Male or female, age equal or greater than 18 years, with no racial/ethnic restrictions;
- •Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
- •Must be in generally stable health;
- •Must sign an informed consent document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits and potential risks, and are willing to participate;
- •Must have, on average ≥ 4/10 units of pain intensity over the course of a 1-4 week period prior to the brain scanning visit;
- •Must be willing to complete daily smartphone/computer eDiary ratings;
- •Must be on regular opioid therapy or for at least 3 months prior to randomization which will be up to the clinical investigator's decision
- •Must be on a short acting opioid therapy (anticipated duration of action < 6 hours)
排除标准
- •Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;
- •Other comorbid chronic pain or neurological conditions;
- •Use of therapeutic doses of antidepressant medications at unstable doses (i.e., tricyclic depressants, SSRIs, SNRIs; low doses used for sleep may be allowed);
- •Significant other unstable medical disease such as diabetes, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy;
- •Uncontrolled hypertension;
- •Renal insufficiency;(correlated creatinine clearance < 40mL/min or serum creatinine ≥2)
- •Daily use of high doses of opioids,, as defined as > 50mg morphine equivalent/day;
- •Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
- •In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
- •Evidence of poor treatment compliance, in the judgment of the investigator;
- •Intra-axial implants (e.g. spinal cord stimulators or pumps);
- •All exclusion criteria for MR safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia;
- •Pregnancy, or inability to use an effective form of contraception in women of child-bearing age;
- •An established diagnosis of diabetes (type 1 or type 2)
- •Lactose intolerance
- •History of an allergic reaction to naproxen or any NSAID;
- •History of any untoward reaction to carbidopa/levodopa
- •Use of a patch or long acting opioid therapy (e.g. anticipated duration of action > 6 hours)
研究组 & 干预措施
Chronic Back Pain with Opioid Use
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows:
- treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid;
- treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or
- treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
干预措施: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet (Drug)
Chronic Back Pain with Opioid Use
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows:
- treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid;
- treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or
- treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
干预措施: Naproxen 500 Mg (Drug)
Chronic Back Pain with Opioid Use
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows:
- treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid;
- treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or
- treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
干预措施: Opioids (Drug)
Chronic Back Pain with Opioid Misuse Disorder
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows:
- treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid;
- treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or
- treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
干预措施: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet (Drug)
Chronic Back Pain with Opioid Misuse Disorder
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows:
- treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid;
- treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or
- treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
干预措施: Naproxen 500 Mg (Drug)
Chronic Back Pain with Opioid Misuse Disorder
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows:
- treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid;
- treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or
- treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
干预措施: Opioids (Drug)
结局指标
主要结局
Differences across drugs in Withdrawal relief assessed by Pain and Craving Index (PCI).
时间窗: 3 weeks
Pain and Drug craving Index (PCI) will be used to evaluate self-reported medication cravings. Participants will complete the scale, before and after receiving the visit drug treatment. Changes in PCI scores (after minus before) will be compared between drugs (opioids vs. placebo vs. Carbidopa/Levodopa +naproxen).
Differences across drugs in pain changes as assessed by Numeric Rating Scale (0-10).
时间窗: 3 weeks
NRS scale will be used to evaluate self-reported pain. Participants will rate their pain before and after receiving the visit drug treatment. Changes in pain scores (after minus before) will be compared between drugs (opioids vs. placebo vs. Carbidopa/Levodopa +naproxen).
次要结局
- Differences in pain changes (NRS) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM).(3 weeks)
- Differences in withdrawal changes (PCI) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM).(3 weeks)
- Whole-cortex multi-receptor related activity(3 weeks)
研究者
Apkar Apkarian
Principal Investigator
Northwestern University