The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids: Effects on Cognition, Pain and Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 82
- Primary Endpoint
- Dose and time dependent effects
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Dose and time dependent effects
Time Frame: 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.
Secondary Outcomes
- Function of the immune and endocrine systems(Up to 2.5 years)
Investigators
Per Sjogren
Professor, M.D., Dr. Med. Sci
Rigshospitalet, Denmark