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Clinical Trials/NCT02277080
NCT02277080CompletedNot Applicable

The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids: Effects on Cognition, Pain and Quality of Life

Rigshospitalet, Denmark0 sites82 target enrollmentStarted: September 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Per Sjogren

Professor, M.D., Dr. Med. Sci

Rigshospitalet, Denmark

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