Status:
COMPLETED
The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Pain
Opioids
Eligibility:
All Genders
18-65 years
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 fu...
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" opio...
Eligibility Criteria
Inclusion
- CRITERIA FOR INCLUSION IN THE OPIOID GROUP
- Age \>18 yrs and \<65 yrs
- Chronic non-cancer pain (\>6 months' duration)
- At least six years of schooling
- Fluent in spoken and written Danish
- On opioid treatment (\>30 mg of morphine equivalents pr. day) for at least one month
- CRITERIA FOR INCLUSION IN THE CONTROL GROUP
- Age \>18 yrs and \<65 yrs
- Chronic non-cancer pain (\>6 months' duration)
- At least six years of schooling
- Fluent in spoken and written Danish (no need for translator)
- No analgesic treatment for the last month
- CRITERIA FOR EXCLUSION
- Treatment with glucocorticoid or sex hormones within the previous 6 months or on-going therapy with drugs known to interfere with endocrine function
- Treatment with adjuvant analgesics (anticonvulsants, antidepressants and others), NSAIDs/paracetamol, benzodiazepines and hypnotics (sleeping pills can be discontinued 3 days before testing) the last month
- Known endocrine disease including insulin treated diabetes mellitus
- Previously diagnosed dementia or encephalopathy
- Brain trauma necessitating hospitalization within last 6 months
- Previously diagnosed liver disease
- Renal insufficiency (serum creatinine concentration \>140 µmol/l)
- Pregnancy
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 28 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT02277080
Start Date
September 1 2014
End Date
December 28 2022
Last Update
March 20 2023
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