Opioid-Redox Study

Summary

Side effects of opioids can from practical view be divided into short-term and long-term. Nervous system disorders are manifested by psychological status changes of the patient and may cause confusion, mental and somatic dependency, dizziness and so on. Influencing the vegetative and cardiovascular system hypotension can occur what is manifestation of vasodilation and decreased myocardial inotropic activity. Another clinical sign is bradycardia and is characterized by general weakness, sweating, collapse can develop. Effects of opioids may cause respiratory depression, bronchospasm and bronchoconstriction. Side effects on the gastrointestinal tract are nausea, vomiting, constipation and less frequently dry mouth. The constipation does not develop tolerance and has to be avoided (dietary modification, laxatives prevention) respectively during long-term opioid treatment obstipation should be affected by blocking peripheral opioid receptors in the gastrointestinal tract by application of an opioid antagonist methylnaltrexone, which does not cross the blood brain barrier, or using naloxone, which is metabolized by "first-pass" metabolism in the liver for example combined preparation containing oxycodone and naloxone (Kulichová, 2012). Known side effects on parenchymatous organ especially on liver is restricted biliary excretion caused by spasm of the biliary tract. Skin manifestations caused by the effects of opioids are urticaria, dermatitis, and pruritus. Renal and urinary disorders may develop as urinary retention and ureteral spasm. Rarely can occur disorders of the immune system, which through the development of hypersensitivity may lead to the development of anaphylactic shock (Kulichová, 2012). Opioids have a negative effect and the endocrine system. Various studies have demonstrated the influence of opioids on regulatory mechanisms. Fundamental changes occur in hypothalamic-pituitary complex, which directs the activities of all the endocrine system. Secretion of hormones of the pituitary gland regulates the nervous system through the hypothalamus, which is the coordination center of autonomic function. The pituitary gland has coordinating function in relation to other endocrine glands, and by production of their hormones affects the peripheral endocrine organs and the targeting tissues (Kulichová, 2012), (Colameco, 2009).

Opioids decrease the secretion of gonadotropin-stimulating hormone, resulting in reduced levels of luteinizing hormone. The result of these changes is reduced secretion of testosterone and estradiol what results in symptoms of hypogonadism. Chronic administration of exogenous opioids decreases the levels of adrenocorticotropic hormone and cortisol, as well as their circadian rhythms. The result is a reduction in the response to stress. Effect on prolactin is not entirely clear. Opioids can stimulate the hypothalamus through the thyroid stimulating hormone, which may cause prolonged and increased response to opioids in patients with hypothyroidism. Chronic use of opioids is associated with weight gain, hyperglycemia and diabetes can worsen (Kulichová, 2012). It may be related to central effects through the sympathetic nervous system and impaired insulin secretion. New laboratory measurements show the development of oxidative stress in patients receiving morphine and related drugs (Merdin, 2016).

The consequences of these biochemical changes further negatively affect the clinical outcome of the patients. They may become predisposed to excessive progression of previously latent diseases whose manifestations in patients previously were not apparent and there is emergence of new diseases. The present data are essential to create a clinical prospective observational studies to clarify this issue and its conclusions would be essential for new therapeutic options for adjuvant therapy in patients suffering from chronic pain.

Conditions

• Opioid Use

Sponsors & Collaborators

• F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

  collaborator OTHER

• Pavol Jozef Safarik University

  lead OTHER

Principal Investigators

• Janka Vašková, MD PhD · Pavol Jozef Šafárik University in Kosice

• Jana Šimonová, MD PhD · Louis Pasteur University Hospital in Košice

• Daniela Ogurčáková, MD PhD · Pavol Jozef Šafárik University in Kosice

• Peter Čandík, MD PhD · East Slovak Institute of Cardiovascular Disease in Kosice

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-20

Primary Completion

2021-11-21

Completion

2022-12-01

Countries

• Slovakia

Study Locations