Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02277080 |
| Other study ID # |
H-1-2014-063 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2014 |
| Est. completion date |
December 28, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Rigshospitalet, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
Other studies have shown that not only are hormones changing during treatment with opioids,
but the immunological function is also affected. There have been shown a link between the
immunological and hormonal function so that parts of the immune system also affect the
pituitary-adrenal function.
Opioid use and misuse per se has long been suspected to be associated with infections because
both the innate and the adaptive immune system are getting affected through a number of
mechanisms.
This study investigates the possibility of hormonal disorders being contributing factor to
the development of cognitive impairment in patients who are in opioid treatment. The same
applies to patients' well-being, mood and pain perception.
STUDY DESIGN
A cross-sectional study will be carried out at Multidisciplinary Pain Centre, Rigshospitalet,
investigating opioid treated chronic non-cancer patients. These patients should have been
treated only with one opioid for more than one month and will be compared to an age,
educational and sex matched control group of chronic non-cancer patients not treated with
analgesics.
STUDY SAMPLE
The study is an explorative study of 25 opioid treated patients and 25 controls.
The patients will be included or excluded for either group on the basis of specific
criterions.
If the hypotheses of the study seem to be confirmed more patients will be included in order
to investigate the effects of different opioid substances.
METHOD
Data will be collected by a trained medical student, who will administer the instruments and
retrieve information from the patients' files.
Hormone assay
The adrenocortical function will be tested with the 30 min ACTH test. Leydig-cell function,
IGF, TSH, thyroxine and prolactine will be measured as well.
Immunology Fresh whole blood will be used for flow cytometry, where the amount of the
different cells in the immune system will be measured. Furthermore, plasma samples (snap
frozen) will be collected (biobank).
The following cell types will be analyzed by using flow cytometry: NK cells, B cells and T
cells. To study the immune response fresh whole blood will be stimulated with pathogens.
Production of cytokines will be examined by analyzes of culture supernatants. Possible
alteration in inflammation will be determined by analysing the plasma samples.
Establishment of research biobank
All material is collected as part of the study. A biobank will be established and blood
samples will be safely stored at Rigshospitalet as long as the study is going on. The purpose
of the research biobank is to use the samples in follow-up studies.
Assessment of cognitive function
Regarding neuropsychological assessment, two instruments were selected:
1. CRT measures sustained attention or vigilance. It is a computer test, in which through
headphones, 100 auditory signals are delivered to the patient at random intervals. The
patient is instructed to press a button as soon as the sound is heard.
2. DST assesses attention/concentration, recent and working memory. Patients are asked to
repeat the series of numbers of increasing lengths, in both forward (direct) and
backward (reverse) order.
Pain evaluation
Patients' pain intensity will be assessed using the Brief Pain Inventory (BPI) measuring pain
at its worst, least and average during the last 24 hours and the current pain intensity.
Mood
Depression and anxiety will be evaluated using the Hospitality Anxiety and Depression Scale
(HADS). Scores above 8 indicates that a depressive or anxiety disorder is likely to be
present.
Health-related quality of life
The Short Form 36 (SF-36) will also be included in the self-administered questionnaire. The
SF-36 is a 36-item survey that measures eight dimensions of health. Higher scores on the
SF-36 (range 0 to 100) indicate better health-related quality of life.
RESULTS
The results will be analysed by using specific statistic tools as descriptive variables,
primary outcome, secondary outcome, significance levels, and clinical significance.
