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The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277080
Recruitment Status : Enrolling by invitation
First Posted : October 28, 2014
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Per Sjogren, Rigshospitalet, Denmark

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.


Condition or disease
Pain Opioids Immune System Endocrine System Quality of Life

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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids: Effects on Cognition, Pain and Quality of Life
Actual Study Start Date : October 2014
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Group/Cohort
Opioid group
These patients should have been treated only with one opioid (morphine, oxycodone, fentanyl, methadone, hydromorphone, tapentadol or tramadol) for more than one month
Control group
Chronic non-cancer pain patients not treated with analgesics



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Function of the immune and endocrine systems [ Time Frame: Up to 2.5 years ]
    Differences on the mean scores of the cognitive tests, pain intensity and quality of life between patients and controls.


Biospecimen Retention:   Samples With DNA
whole blood/serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pain patients at Multidisciplinary Pain Centre at Rigshospitalet, Denmark
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277080


Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Per Sjøgren, Proff. Rigshospitalet, Denmark
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Responsible Party: Per Sjogren, Professor, M.D., Dr. Med. Sci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02277080    
Other Study ID Numbers: H-1-2014-063
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Keywords provided by Per Sjogren, Rigshospitalet, Denmark:
Pain, opioids, immune system, endocrine system, quality of life