Opioid-use DisorderTOPAZENCT03729388
Treatment for Opiate Addiction: Prognostic fActors of Responsiveness to Maintenance Treatment
An observational study of Opioid-use Disorder, run by Nantes University Hospital at 2 sites in France.
Trial summary
A global and integrative treatment of opioid-use disorders (OUD) with opiate maintenance therapy (OMT) and psychosocial interventions is recommended by all current guidelines. Treatment of OUD aim at prevents risks and consequences of opioid use (death by overdose, contamination with infectious diseases, mental and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Prognosis factor associated with good outcome.
- How many people
- 29 participants
- Where
- 2 sitesFrance
- Study dates
- 28 May 2019to 28 May 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include subjects with an opioid-related disorder for whom an OMT is indicated.
Who may be able to join
- Minimum age of 18 years
- Initiation of treatment with OMT (methadone or buprenorphine) for an OUD moderate to severe (according to DSM 5) in Nantes Hospital addictionology department or in an addiction care and prevention centers in Nantes.
- Affiliated to social security
- Consent to participate
Who cannot join
- Upper cerebral function disorder inconsistent with participating in the study
- Difficulty to understand, read or write French language
- Adult under guardianship or curatorr
- Pregnant woman
Trial locations and contacts
2 sites in 1 country.
About this study
A global and integrative treatment of opioid-use disorders (OUD) with opiate maintenance therapy (OMT) and psychosocial interventions is recommended by all current guidelines. Treatment of OUD aim at prevents risks and consequences of opioid use (death by overdose, contamination with infectious diseases, mental and physical degradation, social exclusion and decrease of quality of life). OMT are approved since more than 20 years for OUD and a large number of patients have been treated. Nevertheless, identification of prognosis factors associated with good outcome is still limited. OMT duration, high dosages of OMT and patient good consistency have been identified as good prognosis factors but other individual factors could be involved and explain why OMT isn't as effective for all patients. The investigators assume that social environment, other addictive behaviors, psychiatric comorbidities, personality disorders and pharmacogenetics parameters might be of interest. Association between phenotype/ genotype, safety of OMT and therapeutic outcome will be especially assessed. For voluntary patients specific tools for risk reduction will be implemented (screening of infectious diseases with blood tests and fibrosis with fibroscan). Thus, the aim of TOPAZE study is to highlight prognosis factors for good outcome in the treatment of OUD moderate to severe at 12 months follow-up. Three main axes will be considered: clinical, pharmacological and pharmacogenetics.
Read the detailed description
All patients with moderate or severe OUD diagnosis (according to Diagnostic and Statistical Manual Diploma in Social Medicine 5) who initiate OMT in addictionology department of Nantes hospital or in addiction care and prevention centers of Nantes could be included. Data will be collected during 3 visits.
During the first visit (inclusion), clinical interview, electrocardiogram, urinary and blood tests (pharmacokinetics and pharmacogenetics analysis) will be provided. Infectious disease screening and fibroscan could be also provided as the patient wishes. Inclusion visit will also correspond to initiation of OMT.
At 6 months follow-up (second visit) clinical interview, electrocardiogram, urinary and blood tests (pharmacokinetics and pharmacogenetics analysis) will be provided.
At 12 months follow-up (final visit) clinical interview, electrocardiogram and urinary test will be provided.
- Conditions
- Opioid-use Disorder
- Being tested
- Prognosis factor associated with good outcome.
- Keywords
- Opiate substitution treatment, Opioid-related disorder, Behavior, Addictive, Substance-related disorder, Methadone, Buprenorphine, Prognosis
- Medical subject headings
- Opioid-Related Disorders, Behavior, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognosis factor associated with good outcome.Other
Implementation of a systematic assessment of patient with OMT initiation. Patients included in the TOPAZE study will receive standardized clinical interviews, electrocardiograms, urinary and blood tests during a 12 months follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical, pharmacokinetics and pharmacogenetics characteristics associated with good outcome of patients treated with OMT.
Good outcome is defined as early remission of opioid-related disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth version (none of the diagnostic criteria except craving within last three months) and no initiation or worsening of other addictive behavior (substance use disorders or gambling disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth version within last 12 months).
Measured: 12 months
Secondary outcomes (10)
Prevalence of good outcome after an OMT treatment initiation.
Good outcome is defined as early remission of opioid-related disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth version (none of the diagnostic criteria except craving within last three months) and no initiation or worsening of other addictive behavior (substance use disorders or gambling according to Diagnostic and Statistical Manual of Mental Disorders Fifth version within last 12 months).
Measured: 12 months
Reasons for dropping-out of treatment.
Prevalence of each reason will be described (stopping treatment, death…).
Measured: 12 months
Clinical characteristics of patients: history of psychoactive substance consumptions, psychiatric comorbidities and addictive behaviors, risky behaviors (intravenous administration, sharing equipment and sexual behavior).
Measured: 12 months
Number of participants with variation in the cytochrome P450 (CYP) enzyme with focus on CYP2B6, CYP2C19, CYP2D6, CYP3A4 polymorphisms using next-generation sequencing.
Prevalence of CYP2B6, CYP2C19, CYP2D6 and CYP3A4 variants.
Measured: At inclusion
Pharmacokinetics of OMT elimination.
Residual plasmatic concentration will be considered.
Measured: 6 months
Number of participants with methadone-associated Q-T interval prolongation as assessed by electrocardiogram [safety].
Prevalence of methadone-associated Q-T interval prolongation.
Measured: 12 months
Number of participants who accept to participate to a specific consultation with a hepatologist with a formation in risk reduction.
Prevalence of participants who accept the hepatologist consultation and to be tested with blood tests for viral infections and fibroscan for hepatic fibrosis.
Measured: At inclusion
Number of participants with variation of the Permeability-glycoProtein (P-gP) using next-generation sequencing.
Prevalence of P-gP variants.
Measured: At inclusion
Number of participants with variation in the OPRM1 gene (coding for µ receptor) using next-generation sequencing.
Prevalence of OPRM1 variants.
Measured: At inclusion
Number of participants with urine tests results in accordance with a good compliance [compliance].
Prevalence of participants with positive urine tests results for OMT without any positive urine tests results for illicit substances or drugs without prescription.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start28 May 2019
- Primary completion28 May 2022
- Study completion28 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSAPA Apsyades, OPPELIA-Le triangle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729388
- Sponsor's protocol ID
- RC17_0377
- Acronym
- TOPAZE
- Status last verified
- Aug 2022
- First submitted
- 4 Oct 2018
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Opiate Addiction: Prognostic fActors of Responsiveness to Maintenance Treatment
- ClinicalTrials.gov ID
- NCT03729388
- Acronym / sponsor ID
- TOPAZE / RC17_0377
- Conditions
- Opioid-use Disorder
- Keywords
- Opiate substitution treatment, Opioid-related disorder, Behavior, Addictive, Substance-related disorder, Methadone, Buprenorphine, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- CSAPA Apsyades, OPPELIA-Le triangle
- Study start
- 28 May 2019 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 28 May 2022 (actual)
- First posted
- 2 Nov 2018 (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.
A global and integrative treatment of opioid-use disorders (OUD) with opiate maintenance therapy (OMT) and psychosocial interventions is recommended by all current guidelines. Treatment of OUD aim at prevents risks and consequences of opioid use (death by overdose, contamination with infectious diseases, mental and physical degradation, social exclusion and decrease of quality of life). OMT are approved since more than 20 years for OUD and a large number of patients have been treated. Nevertheless, identification of prognosis factors associated with good outcome is still limited. OMT duration, high dosages of OMT and patient good consistency have been identified as good prognosis factors but other individual factors could be involved and explain why OMT isn't as effective for all patients. The investigators assume that social environment, other addictive behaviors, psychiatric comorbidities, personality disorders and pharmacogenetics parameters might be of interest. Association between phenotype/ genotype, safety of OMT and therapeutic outcome will be especially assessed. For voluntary patients specific tools for risk reduction will be implemented (screening of infectious diseases with blood tests and fibrosis with fibroscan). Thus, the aim of TOPAZE study is to highlight prognosis factors for good outcome in the treatment of OUD moderate to severe at 12 months follow-up. Three main axes will be considered: clinical, pharmacological and pharmacogenetics.
Detailed description
All patients with moderate or severe OUD diagnosis (according to Diagnostic and Statistical Manual Diploma in Social Medicine 5) who initiate OMT in addictionology department of Nantes hospital or in addiction care and prevention centers of Nantes could be included. Data will be collected during 3 visits.
During the first visit (inclusion), clinical interview, electrocardiogram, urinary and blood tests (pharmacokinetics and pharmacogenetics analysis) will be provided. Infectious disease screening and fibroscan could be also provided as the patient wishes. Inclusion visit will also correspond to initiation of OMT.
At 6 months follow-up (second visit) clinical interview, electrocardiogram, urinary and blood tests (pharmacokinetics and pharmacogenetics analysis) will be provided.
At 12 months follow-up (final visit) clinical interview, electrocardiogram and urinary test will be provided.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include subjects with an opioid-related disorder for whom an OMT is indicated.
Key inclusion criteria (4 listed)
- Minimum age of 18 years
- Initiation of treatment with OMT (methadone or buprenorphine) for an OUD moderate to severe (according to DSM 5) in Nantes Hospital addictionology department or in an addiction care and prevention centers in Nantes.
- Affiliated to social security
- Consent to participate
Key exclusion criteria (4 listed)
- Upper cerebral function disorder inconsistent with participating in the study
- Difficulty to understand, read or write French language
- Adult under guardianship or curatorr
- Pregnant woman
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 |
|---|---|---|
| Prognosis factor associated with good outcome.Implementation of a systematic assessment of patient with OMT initiation. Patients included in the TOPAZE study will receive standardized clinical interviews, electrocardiograms, urinary and blood tests during a 12 months follow-up. | Other | – |
Primary outcome
Clinical, pharmacokinetics and pharmacogenetics characteristics associated with good outcome of patients treated with OMT.
Time frame: 12 months
Good outcome is defined as early remission of opioid-related disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth version (none of the diagnostic criteria except craving within last three months) and no initiation or worsening of other addictive behavior (substance use disorders or gambling disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth version within last 12 months).
10 secondary outcomes
Prevalence of good outcome after an OMT treatment initiation.
Time frame: 12 months
Reasons for dropping-out of treatment.
Time frame: 12 months
Clinical characteristics of patients: history of psychoactive substance consumptions, psychiatric comorbidities and addictive behaviors, risky behaviors (intravenous administration, sharing equipment and sexual behavior).
Time frame: 12 months
Number of participants with variation in the cytochrome P450 (CYP) enzyme with focus on CYP2B6, CYP2C19, CYP2D6, CYP3A4 polymorphisms using next-generation sequencing.
Time frame: At inclusion
Pharmacokinetics of OMT elimination.
Time frame: 6 months
Number of participants with methadone-associated Q-T interval prolongation as assessed by electrocardiogram [safety].
Time frame: 12 months
Number of participants who accept to participate to a specific consultation with a hepatologist with a formation in risk reduction.
Time frame: At inclusion
Number of participants with variation of the Permeability-glycoProtein (P-gP) using next-generation sequencing.
Time frame: At inclusion
Number of participants with variation in the OPRM1 gene (coding for µ receptor) using next-generation sequencing.
Time frame: At inclusion
Number of participants with urine tests results in accordance with a good compliance [compliance].
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder, run by Nantes University Hospital at 2 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical, pharmacokinetics and pharmacogenetics characteristics associated with good outcome of patients treated with OMT. (time frame: 12 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 1 Sep 2022.