AddictionMobiCogImNCT02334956
Linking fMRI to Mobile Technologies in Addiction Research: Pathophysiology of Executive Deficits, Craving and Substance Use
A study testing Brain MRI in people with Addiction, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Addiction
- What is being tested?
- Brain MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2015to 10 Jan 2018
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux
Bordeaux, 33000
Hôpital Charles Perrens
Bordeaux, 33076
About this study
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.
Read the 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.
- Conditions
- Addiction
- Being tested
- Brain MRI
- Keywords
- MRI, Executive Deficits
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Patient with addiction Receives: Other: Brain MRI |
| Control | Experimental | healthy subject Receives: Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of correlation between inter-regional hemodynamic signals and clinical and neuropsychological data
Measured: 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
Measured: After the MRI (D2 at 1 month after the inclusion)
Measurements of brain structure, in relation to brain functioning
Measured: After the MRI (D2 at 1 month after the inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startMar 2015
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale
- Responsible party
- Sponsor
- Investigators
- Michèle ALLARD, Prof, Principal investigator, University Hospital, BordeauxJoel SWENDSEN, PhD, Study director, INCIA-UMR-CNRS 5287
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334956
- Sponsor's protocol ID
- CHUBX 2014/19
- Other IDs
- 2014-A01668-39
- Acronym
- MobiCogIm
- Status last verified
- Feb 2019
- First submitted
- 6 Jan 2015
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking fMRI to Mobile Technologies in Addiction Research: Pathophysiology of Executive Deficits, Craving and Substance Use
- ClinicalTrials.gov ID
- NCT02334956
- Acronym / sponsor ID
- MobiCogIm / CHUBX 2014/19
- Conditions
- Addiction
- Keywords
- MRI, Executive Deficits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale
- Study start
- Mar 2015 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 8 Jan 2015 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Other: Brain MRIPatient with addiction |
| Control | Experimental | Other: Brain MRIhealthy subject |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Brain MRI | Other | Control, Patient |
Primary outcome
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)
2 secondary outcomes
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)
Measurements of brain structure, in relation to brain functioning
Time frame: After the MRI (D2 at 1 month after the inclusion)
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 1 Jun 2026.
Related trials for Addiction
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Not yet recruiting
Low-Intensity Focused Ultrasound for Gambling Disorder
Gambling Disorder, Gambling Addiction
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Enrolling by invitationObservational study
Addictions Neuroclinical Assessment (ANA)
Normal Physiology, Alcohol Use Disorder
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.
Michèle ALLARD, Prof principal investigator
University Hospital, Bordeaux
Joel SWENDSEN, PhD study director
INCIA-UMR-CNRS 5287
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI in people with Addiction, run by University Hospital, Bordeaux at 2 sites 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 13 inclusion and 4 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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)). 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 1 Jun 2026.