Opioid-related DisordersCOM-ONNCT01570699
Variation of COMT Val158Met Polymorphism Between COM-ON Patients and METHADOSE Patients
An observational study of Opioid-related Disorders and Opiate Dependence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample of opiate-users without any lifetime opiate dependence. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Opioid-related Disorders, Opiate Dependence, Opiate Addiction
- What is being tested?
- COMT polymorphism
- Type of treatment
- Injection or infusion
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Jun 2016
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects who have consumed illicit opiates (heroin, methadone, buprenorphine or morphine) more than 10 times in their life, without ever having the DSM-IV criteria for opiate dependence or abuse
Who may be able to join
- Patient over 18 years old
- Caucasian patients
- Clinical diagnosis of lifetime opiate-using disorder (consumption over 10 times of illicit opiates (heroin, buprenorphine, methadone or morphine))
- Not lifetime history of opioid dependence (DSMIV)
- Patients with health insurance coverage
- Patient was treated with opioids analgesics to alleviate 2 or 3 in their lives
Who cannot join
- Non-Caucasian patients
- Patients who cannot give their consent and/or who refuse the collection of genetic data
- Patients with no health insurance coverage
Trial locations and contacts
1 site in 1 country.
France1 site
Espace Murger, Consultation toxicomanie, Fernand-Widal Hospital (AP-HP)
Paris, Île-de-France Region, 75010
About this study
Official title: COMT Val158Met Polymorphism in Opiate-using Subjects Without Lifetime Opiate Dependence
The main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample of opiate-users without any lifetime opiate dependence.
Read the detailed description
The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders, including addictions, as well as in impulsivity. In most studies it is the Val allele which is found to be associated with addictive behaviors. The study METHADOSE, which began in 2009, includes opiate-dependent patients substituted by methadone. The preliminary analysis of this study shows a genotype distribution different from that of general population samples, with a greater prevalence of Val / Val and Val / Met genotypes. Will be included in the COM ON study subjects who have consumed illicit opiates (heroin, methadone, buprenorphine or morphine) more than 10 times in their life, without ever having the DSM-IV criteria for opiate dependence or abuse. The study will compare, by means of saliva samples, Val / Val and Val / Met genotypes between the subjects recruited in COM ON and those recruited in METHADOSE. Will also be included auto-questionnaires to identify psychological factors that may constitute risk or protective factors vis-à-vis the development of dependence.
- Being tested
- COMT polymorphism
- Keywords
- Cross-sectional observational study, COMT polymorphism, Opiate-users, Opiate dependence
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMT polymorphismGenetic
The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders including addictions, as well as in impulsivity
| Study group | Role | What they receive |
|---|---|---|
| 2: patients included in METHADOSE study | includes opiate-dependent patients substituted by methadone Receives: Genetic: COMT polymorphism | |
| 1: opiate-non dependent patients | Will be included in the COM ON study subjects who have consumed illicit opiates (heroin, methadone, buprenorphine or morphine) more than 10 times in their life, without ever having the DSM-IV criteria for opiate dependence or abuse Receives: Genetic: COMT polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with each COMT genotype (Val/Val, Val/Met and Met/Met) in the opiate-users' group and in the opiate-dependent subjects' group
Measured: Day 0
Secondary outcomes (9)
Score on the M.I.N.I. (Mini-International Neuropsychiatric Interview) on the day of the inclusion
Measured: Day 0
Score on the BIS (Barratt Impulsivity Scale) on the day of the inclusion
Measured: Day 0
Score on the TCI (Cloninger's Temperament and Character Inventory) on the day of the inclusion
Measured: Day 0
Score on the WURS (Wender Utah Rating Scale) on the day of the inclusion
Measured: Day 0
Score on the ASRS(Self-Report Scale) on the day of the inclusion
Measured: Day 0
Score on the MOPS (Measure Of Parental Style) on the day of the inclusion
Measured: Day 0
Score on the Questionnaire of family breakdowns on the day of the inclusion
Measured: Day 0
Score on the CD-RISC (Connor-Davidson Resilience scale) on the day of the inclusion
Measured: Day 0
Score on the CTQ (Childhood trauma questionnaire) on the day of the inclusion
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-related DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence VORSPAN, MD, MSC, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570699
- Sponsor's protocol ID
- CRC10 073
- Other IDs
- 2011-A00623-38
- Acronym
- COM-ON
- Status last verified
- Sep 2016
- First submitted
- 2 Feb 2012
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMT Val158Met Polymorphism in Opiate-using Subjects Without Lifetime Opiate Dependence
- ClinicalTrials.gov ID
- NCT01570699
- Acronym / sponsor ID
- COM-ON / CRC10 073
- Keywords
- Cross-sectional observational study, COMT polymorphism, Opiate-users, Opiate dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Apr 2012 (estimated)
- 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 main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample of opiate-users without any lifetime opiate dependence.
Detailed description
The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders, including addictions, as well as in impulsivity. In most studies it is the Val allele which is found to be associated with addictive behaviors. The study METHADOSE, which began in 2009, includes opiate-dependent patients substituted by methadone. The preliminary analysis of this study shows a genotype distribution different from that of general population samples, with a greater prevalence of Val / Val and Val / Met genotypes. Will be included in the COM ON study subjects who have consumed illicit opiates (heroin, methadone, buprenorphine or morphine) more than 10 times in their life, without ever having the DSM-IV criteria for opiate dependence or abuse. The study will compare, by means of saliva samples, Val / Val and Val / Met genotypes between the subjects recruited in COM ON and those recruited in METHADOSE. Will also be included auto-questionnaires to identify psychological factors that may constitute risk or protective factors vis-à-vis the development of dependence.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2: patients included in METHADOSE study | – | Genetic: COMT polymorphismincludes opiate-dependent patients substituted by methadone |
| 1: opiate-non dependent patients | – | Genetic: COMT polymorphismWill be included in the COM ON study subjects who have consumed illicit opiates (heroin, methadone, buprenorphine or morphine) more than 10 times in their life, without ever having the DSM-IV criteria for opiate dependence or abuse |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects who have consumed illicit opiates (heroin, methadone, buprenorphine or morphine) more than 10 times in their life, without ever having the DSM-IV criteria for opiate dependence or abuse
Key inclusion criteria (6 listed)
- Patient over 18 years old
- Caucasian patients
- Clinical diagnosis of lifetime opiate-using disorder (consumption over 10 times of illicit opiates (heroin, buprenorphine, methadone or morphine))
- Not lifetime history of opioid dependence (DSMIV)
- Patients with health insurance coverage
Key exclusion criteria (3 listed)
- Non-Caucasian patients
- Patients who cannot give their consent and/or who refuse the collection of genetic data
- Patients with no health insurance coverage
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 |
|---|---|---|
| COMT polymorphismThe COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders including addictions, as well as in impulsivity | Genetic | 1: opiate-non dependent patients, 2: patients included in METHADOSE study |
Primary outcome
Number of subjects with each COMT genotype (Val/Val, Val/Met and Met/Met) in the opiate-users' group and in the opiate-dependent subjects' group
Time frame: Day 0
9 secondary outcomes
Score on the M.I.N.I. (Mini-International Neuropsychiatric Interview) on the day of the inclusion
Time frame: Day 0
Score on the BIS (Barratt Impulsivity Scale) on the day of the inclusion
Time frame: Day 0
Score on the TCI (Cloninger's Temperament and Character Inventory) on the day of the inclusion
Time frame: Day 0
Score on the WURS (Wender Utah Rating Scale) on the day of the inclusion
Time frame: Day 0
Score on the ASRS(Self-Report Scale) on the day of the inclusion
Time frame: Day 0
Score on the MOPS (Measure Of Parental Style) on the day of the inclusion
Time frame: Day 0
Score on the Questionnaire of family breakdowns on the day of the inclusion
Time frame: Day 0
Score on the CD-RISC (Connor-Davidson Resilience scale) on the day of the inclusion
Time frame: Day 0
Score on the CTQ (Childhood trauma questionnaire) on the day of the inclusion
Time frame: Day 0
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 29 Sep 2016.
Related trials for Opioid-related Disorders
RecruitingPhase 2
Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement
Opioid Use Disorder
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingEarly Phase 1
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.
Substance Use Disorder (SUD)
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.
Florence VORSPAN, MD, MSC principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-related Disorders and Opiate Dependence, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 3 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 29 Sep 2016. 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?
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?
Number of subjects with each COMT genotype (Val/Val, Val/Met and Met/Met) in the opiate-users' group and in the opiate-dependent subjects' group (time frame: Day 0). 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 29 Sep 2016.