To unravel cocaine metabolism in patients with cocaine use disorder for the purpose of potentially improving bioanalytical tests for cocaine use
ID
Source
Brief title
Condition
- Other condition
- Psychiatric disorders NEC
Synonym
Health condition
Stoornis in het gebruik van cocaïne
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To observe the metabolic profile of cocaine in urine, saliva and blood of
volunteers with cocaine use disorder participating in heroin-assisted
treatment.
Secondary outcome
To explore whether the bioanalytical method for determining cocaine use in
patients with cocaine use disorder could be improved by quantitative
measurement, measurement of a metabolite other than benzoylecgonine, or
measurement in a different biomatrix (saliva).
Background summary
Cocaine is rapidly converted into many different metabolites after entering the
circulation (see Figure 1 in the study protocol). Benzoylecgonine is the most
abundant metabolite of cocaine and the longest detectable metabolite in the
body following cocaine use. [1] The cut-off value for a positive
benzoylecgonine test in urine is 300 ng/ml. If cocaine is used recreationally,
benzoylecgonine is detectable in urine up to 3 days after cocaine use.[2]
However, benzoylecgonine can still be detected in urine for up to 7-16 days in
patients with CUD.[3] This is partly due to the high cocaine concentrations
relative to the cut-off value in urine of patients with CUD. The median
concentration is 22,562 ng/ml, and at concentrations around 300,000 ng/ml, no
acute toxicity is observed.[1] In addition, the long detectability of
benzoylecgonine in the urine of patients with CUD seems to be caused by tissue
accumulation of benzoylecgonine.[4-6] With repeated exposure to cocaine,
benzoylecgonine is accumulated in tissues. Following cessation of use, the
cocaine is gradually released back into the bloodstream and subsequently into
the urine.[4-6] Due to these mechanisms, cocaine analyses based on
benzoylecgonine can give false-positive results and thereby overestimate
cocaine use. Consequently, benzoylecgonine is not an ideal biomarker for the
detection of cocaine use reduction in patients with CUD.
To date, no suitable method has been developed for measuring or interpreting
cocaine use specifically for patients with CUD. Consequently, within RCTs, the
effect of the drug on cocaine use may be underestimated. To prevent this within
the planned REDUCE trial, we aim to investigate whether we can develop a
bioanalytical method for the determination of cocaine use specifically for
patients with CUD. To develop this bioanalytical method, it is necessary to
conduct a preliminary study within a population similar to that of the study
participants within the REDUCE trial.
The references can be found on pages 28-31 of the study protocol.
Study objective
To unravel cocaine metabolism in patients with cocaine use disorder for the
purpose of potentially improving bioanalytical tests for cocaine use
Study design
Observational study
Study burden and risks
Participants do not directly benefit personally from participating in the
study. The burden of this study includes eight visits to the treatment site.
During all of these visits, subjects have to collect and submit urine and
saliva eight times and undergo an interview in which there is asked about their
recent drug use. In addition, blood will be drawn once during the first study
visit. Sample collection, especially the single blood sample, can be perceived
as burdensome. As this is an observational study where participants are not
exposed to any intervention, the risk of participating in this study is limited
to potential complications of venipuncture.
The study may lead to a bioanalytical method of measuring cocaine use in
patients with CUD that is specific to this patient population, which may allow
better assessment of drug efficacy in RCTs for the treatment of CUD.
Ultimately, this may contribute to an RCT that could lead to an effective drug
treatment for CUD.
We believe that the benefits of the research are proportionate to the burden on
participants.
Monsterseweg 93
s Gravenhage 2553 RJ
NL
Monsterseweg 93
s Gravenhage 2553 RJ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Age between 18 and 65 years of age;
2. Moderate or severe cocaine use disorder according to DSM-5 (>=4 criteria);
3. Active participation in heroine-assisted treatment;
4. Snorting, inhaling or injecting cocaine use as primary route of
administration;
5. Able and willing to provide one blood sample;
6. Able and willing to provide urine- and saliva-samples and to be interviewed
about recent drug use for 2 times per week during 4 consecutive weeks;
7. Understanding and speaking Dutch;
8. Able and willing to give written informed consent.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Does not have a sufficiently good understanding of Dutch for informed
consent.
Design
Recruitment
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL86849.058.24 |