The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduction in plasma inflammatory biomarkers
研究概览
简要总结
The main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior work in which we showed that chronic fatigue symptoms are associated with immune activity, and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is thought to share some pathophysiological and clinical characteristics with CFS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind trial. An encrypted and password-protected database will contain (1) information about individual group assignment, and (2) blister pack codes (medication will be dispensed in blister packs by investigators based on these codes). An investigator not involved with data collection or participant interactions will randomly assign individuals to the treatment group and provide blister pack ID codes for each individual.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet the 1994 Case Definition criteria for CFS (assessed through semi-structured interview and the DePaul University Fatigue Questionnaire):
- •Criteria:
- •Severe chronic fatigue ≥6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue;
- •Fatigue interferes with daily activities and work;
- •Reports ≥4 symptoms that started with or after the fatigue, from:
- •Post-exertion malaise >24 hours
- •Unrefreshing sleep
- •Short-term memory or concentration impairment
- •Muscle pain
- •Joint pain without swelling or redness
- •Headaches of a new type/pattern/severity
- •Lymph node tenderness
- •Frequent or recurring sore throat
- •CFS symptoms for ≥12 months
- •Participant completes daily self-report during the 4-week baseline period;
- •Able to attend UAB on all scheduled appointments
排除标准
- •Blood draw contraindicated or otherwise not able to be performed
- •High-sensitivity c-reactive protein (HS-CRP) ≥3 mg/L
- •Erythrocyte sedimentation rate (ESR) >60 mm/hr
- •Positive rheumatoid factor
- •Positive anti-nuclear antibody (ANA)
- •Levels of thyroid stimulating hormone or free thyroxine outside UAB lab reference values
- •Diagnosed rheumatological or auto-immune condition
- •Clotting disorder
- •Use of blood thinning medication
- •Oral temperature >100˚F at baseline
- •Febrile illness or use of antibiotics in the 4 weeks before study commencement;
- •Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement
- •Pregnant or planning on becoming pregnant within 6 months
- •Regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen)
- •Known allergy or adverse effects following naltrexone or naloxone administration
- •Opioid use (self-reported or positive on urine test)
- •Significant psychological comorbidity that in the discretion of the investigator compromises study integrity and/or a baseline HADS depression subscale score of ≥16
- •Current litigation or worker's compensation claim
- •Current participation in another treatment trial
- •Vaccinated in the 4 weeks before study commencement (vaccination during the study period is allowed as long as the drug is administered at least 4 weeks prior to a study blood draw).
研究组 & 干预措施
LDN arm
Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) x24 weeks
干预措施: Naltrexone HCl (Drug)
Placebo/LDN arm
Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) Placebo
Individuals will be switched between drugs as per approved schedule during the 24 weeks.
干预措施: Naltrexone HCl (Drug)
结局指标
主要结局
Reduction in plasma inflammatory biomarkers
时间窗: Four-week baseline; 12 weeks drug
Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest.
次要结局
- Reduction in self-reported symptoms of (i) depression, (ii) anxiety(12 weeks drug)
- Durability of reduction in plasma inflammatory biomarkers(Baseline; 12 weeks drug; 24 weeks drug)
- Reduction in self-reported fatigue(12 weeks drug)
- Increase in physical function(12 weeks drug)
研究者
Jarred Younger
Associate Professor
University of Alabama at Birmingham