Clinical trial · Observational
The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids
The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids: Effects on Cognition, Pain and Quality of Life
NCT02277080CI-TRIAL-00064848completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endocrine System | — | UNRESOLVED | — |
| Immune System | — | UNRESOLVED | — |
| Opioids | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Opioid group
- description
- These patients should have been treated only with one opioid (morphine, oxycodone, fentanyl, methadone, hydromorphone, tapentadol or tramadol) for more than one month
- label
- Control group
- description
- Chronic non-cancer pain patients not treated with analgesics
Primary outcomes (1)
- measure
- Dose and time dependent effects
- timeFrame
- Up to 2.5 years
- description
- Differences on the mean results of endocrine and immunologic blood tests between patients and controls, considering dose and time dependent effects.
Secondary outcomes (1)
- measure
- Function of the immune and endocrine systems
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.