NL-OMON55974尚未招募2 期
THE IMPACT OF PSILOCYBIN ON PAIN IN FIBROMYALGIA PATIENTS: A MULTICENTER TRIAL - THE IMPACT OF PSILOCYBIN ON PAIN IN FIBROMYALGIA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Age between 18 and 65 years
- •Normal weight, body mass index (weight/height2) between 18 and 30 kg/m2
- •Fulfilment of the American College of Rheumatology criteria for FM diagnosis
- •A minimum NRS pain score of 5 out of 10
- •Proficient knowledge of the Dutch or English language
- •Written Informed Consent
- •Understanding the procedures and the risks associated with the study
- •No use of regular use of psychotropic medication such as opiates,
- •antidepressants, muscle relaxants, anticonvulsants, sleep aids,
- •benzodiazepines. Non pharmacological regimens will be allowed along 1 rescue
- •therapy such as acetaminophen <=4,000 mg/day, ibuprofen <=1,200 mg/day, naproxen
- •<=660 mg/day, or ketoprofen <=75 mg/day. Use of paracetamol (PCM) and
- •non-steroidal anti-inflammatory drugs (NSAIDS) will be allowed and monitored.
- •Willingness to refrain from taking psychoactive substances during the study.
- •Willingness to drink only alcohol-free liquids and no coffee, black or green
- •tea, or energy drinks after midnight of the evening before the study session,
- •as well as during the study days
- •Willingness not to drive a traffic vehicle or to operate machines within 24 h
- •after substance administration
排除标准
- •Fibromyalgia Patients:
- •Presence of any other painful condition such as inflammatory rheumatic
- •diseases, migraines or headaches and of other chronic or acute medical
- •Presence of any other psychiatric condition such as primary major depressive
- •disorder, anxiety disorders or substance use
- •Have a history of psychotic or bipolar disorders
- •Previous experience of serious side effects to psychedelic drugs (anxiety or
- •panic attacks)
- •Tobacco smoking (>20 cigarettes per day)
- •Excessive drinking (>20 alcoholic consumptions per week)
- •Psychotic disorder in first-degree relatives
- •Pregnancy or lactation
- •Hypertension (diastolic >90 mmHg; systolic >140 mmHg)
- •History of cardiac dysfunctions (arrhythmia, ischemic heart disease*)
- •For women: no use of a reliable contraceptive
研究者
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