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

February 22, 2019 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux
      • Bordeaux, France, 33076
        • Hôpital Charles Perrens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patient
Patient with addiction
Other: Brain MRI
EXPERIMENTAL: Control
healthy subject
Other: Brain MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
After the MRI (D2 at 1 month after the inclusion)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
After the MRI (D2 at 1 month after the inclusion)
Measurements of brain structure, in relation to brain functioning
Time Frame: After the MRI (D2 at 1 month after the inclusion)
After the MRI (D2 at 1 month after the inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Fondation pour la Recherche Médicale

Investigators

  • Principal Investigator: Michèle ALLARD, Prof, CHU Bordeaux
  • Study Director: Joel SWENDSEN, PhD, INCIA-UMR-CNRS 5287

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

January 10, 2018

Study Completion (ACTUAL)

January 10, 2018

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (ESTIMATE)

January 8, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2014/19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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