NCT02334956

Brief Summary

120 individuals with alcohol, cannabis or nicotine dependence as well as healthy controls will be administered a whole-brain imaging exam. The current research project constitutes a highly novel approach to understanding the pathophysiology of addiction through its combination of neuroimaging with state-of-the-art information concerning the real-time expression of risk factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

January 6, 2015

Last Update Submit

February 22, 2019

Conditions

Addiction

Keywords

MRIExecutive Deficits

Outcome Measures

Primary Outcomes (1)

  • Coefficient of correlation between inter-regional hemodynamic signals and clinical and neuropsychological data

    After the MRI (D2 at 1 month after the inclusion)

Secondary Outcomes (2)

  • Measurements of daily life functioning through recorded data about craving sensation and executive functioning

    After the MRI (D2 at 1 month after the inclusion)

  • Measurements of brain structure, in relation to brain functioning

    After the MRI (D2 at 1 month after the inclusion)

Study Arms (2)

Patient

EXPERIMENTAL

Patient with addiction

Other: Brain MRI

Control

EXPERIMENTAL

healthy subject

Other: Brain MRI

Interventions

Brain MRIOTHER
ControlPatient

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-64 years
  • Being affiliated to health insurance
  • Participation in the study MOBICOG for patients with addiction
  • Fulfils diagnostic criteria for one of the following groups:
  • Group A: Patients with current (last 12 months) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) substance addiction (Alcohol / Cannabis / Nicotine); initiation of treatment for addiction within 30 days preceding enrollment in the study; absence of other axis 1 psychiatric disorder currently being treated (by psychotherapy or pharmacotherapy); absence of current or lifetime bipolar disorder or schizophrenia.
  • Group AM: Patients with current (last 12 months) DSM-IV substance addiction (Alcohol / Cannabis / Nicotine); initiation of treatment for addiction within 30 days preceding enrollment in the study; presence of currently treated unipolar mood disorder (by psychotherapy or pharmacotherapy); absence of current or lifetime bipolar disorder or schizophrenia.
  • Group AS: Patients currently treated for DSM-IV schizophrenia (last 12 months) with DSM-IV substance addiction (Alcohol / Cannabis / Nicotine); absence of other axis 1 psychiatric disorder currently being treated (by psychotherapy or pharmacotherapy); absence of current or lifetime bipolar disorder.
  • Aged 18-64 years
  • Participation in the study MOBICOG
  • Being affiliated to health insurance
  • Healthy volunteers without current addiction and with no other currently-treated axis 1 DSM-IV disorder (by psychotherapy or pharmacotherapy); absence of current or lifetime bipolar disorder or schizophrenia

You may not qualify if:

  • Presence of a counter-indication for MRI
  • Presence of any health problem preventing travel to the imaging service of the University Hospital
  • Being unable to provide consent to participate
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Hôpital Charles Perrens

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Michèle ALLARD, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Joel SWENDSEN, PhD

    INCIA-UMR-CNRS 5287

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 8, 2015

Study Start

March 1, 2015

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

FR(2)