Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05740657 |
Other study ID # |
2022-01693 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 6, 2022 |
Est. completion date |
December 2023 |
Study information
Verified date |
February 2023 |
Source |
University of Zurich |
Contact |
Tina M. Binz, Dr. |
Phone |
+41 44 635 7614 |
Email |
TinaMaria.Binz[@]irm.uzh.ch |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The goal of this fundamental research study is to learn how opioids are incorporated into
hair after application of opioids to newborns, infants and children in a controlled medical
setting. The main questions aimed to answer are: Are opioids (specifically fentalogs)
incorporated into hair? Are opioids detectable in sweat and does sweat influence the
incorporation into hair? Can normative opioid value ranges be established in hair? Can these
values help to for interpretation of opioid positive hair results and ultimately help
distinguish between medical opioid intake and intake of illegal designer opioids? Hair
samples from 150 patients will be taken as well as 75 sweat sample and analyzed for their
opioid concentrations. Investigators hypothesize that opioids will be detectable in hair and
sweat and that the cohort size will allow to establish normative value ranges that will help
for interpretation of hair results in forensic toxicology.
Description:
In recent years, new synthetic opioids (NSOs) have emerged in the illicit drug supply in an
increasing rate. Many of these new registered opioids can structurally be assigned to the so
called fentalogs, which are pharmacologically active derivatives of the approved pain
management drug fentanyl. Many of these compounds are highly potent, relatively cheap and
thereby especially fueling the current opioid crisis in the USA and posing a significant
challenge for authorities, the healthcare system and forensic toxicology globally. Most of
the time opioids are consumed without the user's knowledge as they are sold as heroin or
counterfeit prescription pills like oxycodone or Xanax® which further increases the dangers
posed by this problematic substance class. Recent cases of designer fentanyl intoxication
show that this problem is also encountering Switzerland. Due to their potency, overdoses of
the above-mentioned substances quickly occur, which in absence of intensive medical support
can be fatal even when the antagonist naloxone is used. In order to better address the NSOs
related socio-economic and health care problems, a fundamental understanding of these
substance classes is essential.
As a consequence of the increasing prevalence of designer opioids, forensic and clinical
laboratories worldwide are continuously challenged with updating their analytical methods for
the identification and quantification of these new drugs in various biological matrices. The
classical matrices used in forensic toxicology are blood and urine which represent time
windows of hours to days. Keratinized matrices like hair and nail are considered
complementary matrices as they provide additional information to the more traditional
matrices covering time windows up to several months. The analysis of hair (a keratinized
matrix) can provide significant information about the intake of opioids over extended time
periods and therefore can provide access to a much wider diagnostic window than blood or
urine. It allows getting information about a past exposure to the substance, repeated intake
or even a single intake.
According to the Swiss Society of Legal Medicine, Swiss laboratories that offer forensic hair
analysis must be able to quantify opioids in hair. The analysis of classical opioids like
morphine and respective metabolites is well established in hair. However, knowledge about the
incorporation of medically used fentalogs (e.g. fentanyl, remifentanil and sufentanil) and
illegal designer fentalogs in hair is still limited.
The goal of this study is to gain knowledge about the incorporation and concentration of
fentalogs in hair to help establish a high forensic standard for the detection these new
substances. The specific aim of this study is to analyze hair samples from patients
(children) of a study cohort described below which received medically approved fentalogs
(either fentanyl, remifentanil or sufentanil) and to gain insights into the deposition of
these substances into hair. The investigators will focus on a study cohort (150 patients)
that has received medical fentanyl for pain management therapy in a clinical and therefore
controlled setting. Furthermore, the study cohort consists of children which have some
benefits to address the above raised research question. The hair of children is thinner and
more porous than adult's hair, so that substances can incorporate into hair more easily. This
makes children's hair an ideal target for our research study to see if fentalogs will be
incorporated into hair. Furthermore, it is known that cosmetic treatment like e.g. bleaching
etc. destroys substance that are incorporated in hair, therefore cosmetically treated hair is
not suitable for the study. The probability that young children have cosmetically treated
hair is considered very low.
As substances are incorporated into hair via sweat and blood, the analysis of these matrices
can help to understand the general incorporation mechanisms of substances into hair.
Therefore, the investigators intend to additionally analyze sweat samples from children to
gain knowledge about fentalog concentrations and metabolites in sweat which can be helpful to
understand their incorporation into hair.
The knowledge of this study can be used in forensic toxicology to distinguish between the
intake of medically prescribed opioids and illegal new synthetic opioids.