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

NCT02277080 | Completed

• 1 other identifier: H-1-2014-063
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Opioids; Immune System; Endocrine System; Quality of Life

Keywords

Pain, opioids, immune system, endocrine system, quality of life

Outcome Measures

Primary Outcomes (1)

• Dose and time dependent effects

  Differences on the mean results of endocrine and immunologic blood tests between patients and controls, considering dose and time dependent effects.

  Up to 2.5 years

Secondary Outcomes (1)

• Function of the immune and endocrine systems

  Up to 2.5 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pain patients at Multidisciplinary Pain Centre at Rigshospitalet, Denmark

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Biospecimen

Retention: SAMPLES WITH DNA

whole blood/serum

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Per Sjøgren, Proff.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D., Dr. Med. Sci

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 28, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2021
• Study Completion: December 28, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03