ToxicomaniaPKMETHAHOMENCT05490732
Pharmacokinetic Modeling of Methadone
A study testing Blood sampling in people with Toxicomania, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Toxicomania
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients on methadone on the same dosage for at least 7 days.
- Hospitalization for withdrawal in the addictology department of La Colombière or consultation within the unit for the treatment of drug addiction and dependence (Addictology Department).
- 24 hours monitoring is possible and accepted
Who cannot join
- Patients that cannot be sampled because of weakened veins
- Unable to received information about the study
- Adult protected by law or patient under guardianship
- Not affiliated to french social security system
- Not able to give written inform consent
- Pregnant or breastfeeding woman
- Underaged patients (under 18 years old)
- Patient under court protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier
Montpellier
Hélène Donnadieu, MD, +33467338154, h-donnadieu@chu-montpellier.fr
About this study
Official title: Pharmacokinetic Population Modeling of Methadone in Patients Managed for Opioid Opioid Addiction
The management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. Understanding this variability is potentially to be able to adjust a priori a dosage and to identify the factors of clinical response. Few population pharmacokinetic models exist for methadone and they generally concern the management of pain in palliative care patients or the management of opioid withdrawal syndrome in neonates. The hypothesis is therefore that the creation of such a model would make it possible to reduce patients' withdrawal periods, to set a target for plasma concentrations with a view to reducing dosages, and to empower the patient in his choice to monitor blood concentrations facilitated by a minimally invasive sampling device.
- Conditions
- Toxicomania
- Being tested
- Blood sampling
- Keywords
- pharmacokinetics, methadone, microsampling, modeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Also called Volumetric absorptive microsampling
Patient will be subjected to 3 blood sampling over 24hours. At H0, H4 and H12-24.
For each one, one microsampling and one venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic drug monitoring of methadone | Experimental | 6 samplings per subject: 3 venipunctures and 3 microsamplings Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction.
Measured: 18 months
Secondary outcomes (2)
C12h-24h concentration
To evaluate and estimate methadone/EDDP (metabolite) concentration between 12 and 24h post-administration for patients treated for opioid addiction.
Measured: 18 months
Residual concentration (C0)
To evaluate and estimate residual methadone/EDDP (metabolite) concentration for patients treated for opioid addiction.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start23 Mar 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxicomaniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoann Cazaubon, phD,pharmD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490732
- Sponsor's protocol ID
- 21_0614
- Acronym
- PKMETHAHOME
- Status last verified
- Nov 2024
- First submitted
- 21 Jul 2022
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Population Modeling of Methadone in Patients Managed for Opioid Opioid Addiction
- ClinicalTrials.gov ID
- NCT05490732
- Acronym / sponsor ID
- PKMETHAHOME / 21_0614
- Conditions
- Toxicomania
- Keywords
- pharmacokinetics, methadone, microsampling, modeling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. Understanding this variability is potentially to be able to adjust a priori a dosage and to identify the factors of clinical response. Few population pharmacokinetic models exist for methadone and they generally concern the management of pain in palliative care patients or the management of opioid withdrawal syndrome in neonates. The hypothesis is therefore that the creation of such a model would make it possible to reduce patients' withdrawal periods, to set a target for plasma concentrations with a view to reducing dosages, and to empower the patient in his choice to monitor blood concentrations facilitated by a minimally invasive sampling device.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic drug monitoring of methadone | Experimental | Biological: Blood sampling6 samplings per subject: 3 venipunctures and 3 microsamplings |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major patients on methadone on the same dosage for at least 7 days.
- Hospitalization for withdrawal in the addictology department of La Colombière or consultation within the unit for the treatment of drug addiction and dependence (Addictology Department).
- 24 hours monitoring is possible and accepted
Key exclusion criteria (8 listed)
- Patients that cannot be sampled because of weakened veins
- Unable to received information about the study
- Adult protected by law or patient under guardianship
- Not affiliated to french social security system
- Not able to give written inform consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingAlso: Volumetric absorptive microsamplingPatient will be subjected to 3 blood sampling over 24hours. At H0, H4 and H12-24. For each one, one microsampling and one venipuncture | Biological | Therapeutic drug monitoring of methadone |
Primary outcome
Peak concentration (Cmax)
Time frame: 18 months
To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction.
2 secondary outcomes
C12h-24h concentration
Time frame: 18 months
Residual concentration (C0)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yoann Cazaubon, phD,pharmD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Toxicomania, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoann Cazaubon, phD,pharmD (+33467336261, yoann.cazaubon@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration (Cmax) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.