NCT01570699

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

3.5 years

First QC Date

February 2, 2012

Last Update Submit

September 28, 2016

Conditions

Opioid-related DisordersOpiate DependenceOpiate AddictionOpiate Abuse

Keywords

Cross-sectional observational studyCOMT polymorphismOpiate-usersOpiate dependence

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 0

Secondary Outcomes (9)

  • Score on the M.I.N.I. (Mini-International Neuropsychiatric Interview) on the day of the inclusion

    Day 0

  • Score on the BIS (Barratt Impulsivity Scale) on the day of the inclusion

    Day 0

  • Score on the TCI (Cloninger's Temperament and Character Inventory) on the day of the inclusion

    Day 0

  • Score on the WURS (Wender Utah Rating Scale) on the day of the inclusion

    Day 0

  • Score on the ASRS(Self-Report Scale) on the day of the inclusion

    Day 0

  • +4 more secondary outcomes

Study Arms (2)

2: patients included in METHADOSE study

includes opiate-dependent patients substituted by methadone

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

Genetic: COMT polymorphism

Interventions

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

1: opiate-non dependent patients2: patients included in METHADOSE study

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • Non-Caucasian patients
  • Patients who cannot give their consent and/or who refuse the collection of genetic data
  • Patients with no health insurance coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Espace Murger, Consultation toxicomanie, Fernand-Widal Hospital (AP-HP)

Paris, Île-de-France Region, 75010, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will compare polymorphism COMT between COM-ON patients and METHADOSE patients. Samples may be blood sample or salivary sample.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Florence VORSPAN, MD, MSC

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2012

First Posted

April 4, 2012

Study Start

December 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

FR(1)