NCT02192398终止不适用
Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Numeric Pain Score (0-10: 0 Being no Pain; 10 Being the Worst Pain)
研究概览
简要总结
Combination of guanfacine with opioid medication as a standard treatment for chronic pain.
详细描述
This aim proposes that guanfacine would be a useful drug to reverse Opioid-Induced Hyperalgesia (OIH) when combined with opioids in chronic pain management.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Chronic neck or back pain condition for at least 6 months
- •VAS score of 4-8, despite opioid therapy
- •On a stable morphine equivalent dose of at least 60mg/day and ≤ 240mg/day for at least 3 months
排除标准
- •Has taken Methadone, Suboxone, Fentanyl, and/or Tramadol in the last six (6) months
- •Has taken guanfacine (or other alpha-2AR agonists) in the last six (6) months
- •Changes to current or adding new pain treatment while enrolled in the study (i.e. opiates, epidural steroid injection) will be reviewed by the study physician
- •Unable to independently provide informed written consent
- •Sensory deficits at site of QST, such as peripheral neuropathy
- •Intolerable allergies or has had a severe adverse reaction to study medication (i.e. guanfacine, lactose, vitamin B2 a.k.a. riboflavin)
- •Takes vitamin B2 > 1.6mg/day during the study
- •Pregnant or breastfeeding
- •Pending litigation related to neck or back pain
- •Diagnosed with Raynaud's syndrome
- •Has other chronic pain conditions such as fibromyalgia or joint osteoarthritis that are predominant over back and neck pain with regard to its intensity (VAS)
- •Has known pre-existing severe cardiovascular disease (i.e. arrhythmia - prolonged QT interval > 440ms), cerebrovascular disease/accident (i.e., stroke), hepatic or renal impairment, CNS condition, metabolic condition, or history of syncope
- •Hypotension (SBP < 90 mmHg and DBP < 60 mmHg for female or SBP < 100 mmHg and DBP < 60 mmHg for male; measured while in a sitting position) will be reviewed by a study physician
- •Bradycardia (resting heart rate < 60 bpm) will be reviewed by a study physician
- •Subjects are on antihypertensive drugs (e.g., a beta-blocker) that result in hypotension and/or bradycardia as defined above
- •Tests positive for illicit drugs, marijuana, or non-prescribed drugs
- •Major psychiatric disorders that required hospitalization in the past 6 months such as: major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorders
- •Currently in a treatment program for alcohol or drug abuse, or currently on methadone or buprenorphine (i.e. suboxone, subutex) for treatment of addiction, or currently prescribed stimulants for treatment of ADHD
- •History of substance or alcohol abuse (meets DSM IV criteria) per medical record or subject admission
- •Subjects are on medications that serve as CYP3A4/5 inhibitors or CYP3A4 inducers including, but are not limited to, valproic acid, macrolide antibiotics, antifungal drugs, St. John wort, ACE inhibitors, nefazodone (antidepressant), calcium channel blockers, H2-receptor antagonists, anti-HIV or AIDS drugs, and antiepileptic drugs
- •Subjects are on medications that are ligands for alpha2-adrenergic receptors including antipsychotic drugs (e.g. clozapine) and tricyclic or tetracyclic antidepressants (e.g. imipramine, mirtazapine, mianserin). Any medications taken by a subject at the enrollment will be reviewed regarding their compatibility with guanfacine as well as possible confounding side effects. Subjects will be allowed to take non-opioid pain medications except for gabapentinoids and amitriptyline/nortriptyline as far as such medications do not have incompatibility with guanfacine.
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects will be randomized into 1 of the following 3 treatment groups:
- guanfacine (2mg)
- guanfacine (1mg)
- placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
干预措施: Placebo (Drug)
Guanfacine (1mg)
Active Comparator
Subjects will be randomized into 1 of the following 3 treatment groups:
- guanfacine (2mg)
- guanfacine (1mg)
- placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
干预措施: Guanfacine (Drug)
Guanfacine (2mg)
Active Comparator
Subjects will be randomized into 1 of the following 3 treatment groups:
- guanfacine (2mg)
- guanfacine (1mg)
- placebo
Subjects will be instructed to take one capsule in the evening for 4 weeks.
干预措施: Guanfacine (Drug)
结局指标
主要结局
Numeric Pain Score (0-10: 0 Being no Pain; 10 Being the Worst Pain)
时间窗: baseline and 4 weeks
Changes in numeric pain score (as indicated in Outcome Measure Title) will be used to compare the 3 treatment groups.
次要结局
未报告次要终点
研究者
Jianren Mao, MD, PhD
Principal Investigator
Massachusetts General Hospital
研究点 (1)
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