The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids: Effects on Cognition, Pain and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Dose and time dependent effects
研究概览
简要总结
The primary aim is to investigate the dose and time dependent effects of different opioids on the immune and endocrine systems.
The secondary aim is to investigate whether associations between the function of the immune and endocrine systems and opioid use influence cognitive function, pain and quality of life.
详细描述
BACKGROUND
Epidemiological data from the US and Denmark have shown that 3-5% of the population use opioids for treatment of chronic pain conditions.
Long-term use of opioids may cause "classic" opioid-induced adverse effects, but also serious consequences such as hyperalgesia, cognitive disorders, and suppression of the immune and endocrine systems.
Relatively few studies suggest that these substances affect hormone function in humans. The best studied is the circumstances regarding sex hormones.
A single systematic study and several clinical observations suggest that both pituitary-adrenal function and formation of growth hormone is also reduced by opioids.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Dose and time dependent effects
时间窗: Up to 2.5 years
Differences on the mean results of endocrine and immunologic blood tests between patients and controls, considering dose and time dependent effects.
次要结局
- Function of the immune and endocrine systems(Up to 2.5 years)
研究者
Per Sjogren
Professor, M.D., Dr. Med. Sci
Rigshospitalet, Denmark