search
Back to results

Linking fMRI to Mobile Technologies in Addiction Research: Pathophysiology of Executive Deficits, Craving and Substance Use (MobiCogIm)

Primary Purpose

Addiction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brain MRI
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Addiction focused on measuring MRI, Executive Deficits

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inclusion criteria patient:
  • Aged 18-64 years
  • Being affiliated to health insurance
  • Having signed an informed consent (later than the day of inclusion and before any examination required by research)
  • 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.

Inclusion criteria healthy volunteers:

  • Aged 18-64 years
  • Participation in the study MOBICOG
  • Being affiliated to health insurance
  • Having signed an informed consent (later than the day of inclusion and before any examination required by research)
  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU de Bordeaux
  • Hôpital Charles Perrens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient

Control

Arm Description

Patient with addiction

healthy subject

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measurements of daily life functioning through recorded data about craving sensation and executive functioning
Measurements of brain structure, in relation to brain functioning

Full Information

First Posted
January 6, 2015
Last Updated
February 22, 2019
Sponsor
University Hospital, Bordeaux
Collaborators
Fondation pour la Recherche Médicale
search

1. Study Identification

Unique Protocol Identification Number
NCT02334956
Brief Title
Linking fMRI to Mobile Technologies in Addiction Research: Pathophysiology of Executive Deficits, Craving and Substance Use
Acronym
MobiCogIm
Official Title
Linking fMRI to Mobile Technologies in Addiction Research: Pathophysiology of Executive Deficits, Craving and Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Fondation pour la Recherche Médicale

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background : Despite the availability of both pharmacological and psychosocial treatments, most affected individuals will experience addiction as a chronic illness with severe consequences for health outcome. A fundamental challenge to researchers in this domain is therefore to understand the mechanisms leading to relapse. Among the key vulnerability factors associated with addiction chronicity, increasing attention has focused on deficits in executive functions and associated traits (impulsivity, risk taking) that are likely to explain why many individuals with addiction are unable to avoid high-risk contexts or to manage the experience of craving. Research concerning this vulnerability to relapse has been hindered by the manner in which cognitive deficits are traditionally assessed in clinical research. Most commonly, they are thought to represent stable risk factors that show little or no variation within a given individual. However, executive functioning may fluctuate rapidly over time (as does attention, memory, or other key cognitive functions), and therefore comparisons of overall or 'mean' cognitive deficits between healthy and substance-dependent individuals may show no significant differences despite powerful effects of this vulnerability. Therefore, the absence of measurement or characterization of this important relapse mechanism prevents any further research concerning its underlying pathophysiology. Purpose : Deficits in executive functioning may explain why many individuals with addiction are unable to avoid high-risk contexts or manage the experience of craving that lead to substance use. The principal objective of this project is to acquire resting state functional Magnetic Resonance Imaging (fMRI) and diffusion tensor imaging (DTI) data on patients with current addiction who will then complete (through a distinct protocol) mobile assessments of daily life executive fluctuations, craving, and substance use. Detailed description: 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 collected through an independent investigation concerning the real-time expression of risk factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction
Keywords
MRI, Executive Deficits

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
Patient with addiction
Arm Title
Control
Arm Type
Experimental
Arm Description
healthy subject
Intervention Type
Other
Intervention Name(s)
Brain MRI
Primary Outcome Measure Information:
Title
Coefficient of correlation between inter-regional hemodynamic signals and clinical and neuropsychological data
Time Frame
After the MRI (D2 at 1 month after the inclusion)
Secondary Outcome Measure Information:
Title
Measurements of daily life functioning through recorded data about craving sensation and executive functioning
Time Frame
After the MRI (D2 at 1 month after the inclusion)
Title
Measurements of brain structure, in relation to brain functioning
Time Frame
After the MRI (D2 at 1 month after the inclusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria patient: Aged 18-64 years Being affiliated to health insurance Having signed an informed consent (later than the day of inclusion and before any examination required by research) 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. Inclusion criteria healthy volunteers: Aged 18-64 years Participation in the study MOBICOG Being affiliated to health insurance Having signed an informed consent (later than the day of inclusion and before any examination required by research) 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michèle ALLARD, Prof
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joel SWENDSEN, PhD
Organizational Affiliation
INCIA-UMR-CNRS 5287
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Charles Perrens
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Learn more about this trial

Linking fMRI to Mobile Technologies in Addiction Research: Pathophysiology of Executive Deficits, Craving and Substance Use

We'll reach out to this number within 24 hrs