AddictionCARDEMANCT07734363
Role of Craving in the Transition Across Level of Addiction Severity: A Longitudinal Study.
An observational study of Addiction, run by University of Bordeaux at 1 site in France.
Trial summary
Substance/Alcohol Use disorders are defined as a loss of control over the use despite harmul consequences, as well as an intense and persistent urge to use, also called craving. Previous research has shown that craving is central among the diagnostic criteria for addiction, suggesting that it may be important in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction
- What is being tested?
- Observational assessments (EMA and annual DSM-5 evaluations)
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2026to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have initiated treatment for addiction in a Centre de Soin et d'Accompagnement et de Prévention en Addictologie in France; People with addiction recruited from the general population via recruitment campaigns (posters, partner institutions websites, newspaper, social media); Users of Kanopée, a smartphone application developed by SANPSY Lab, who reported problematic tobacco, alcohol or cannabis use.
Who may be able to join
- Be over 18 years of age
- Identify a primary substance as a main problematic substance use.
- Be a regular user (at least twice a week in the last 30 days) of a primary substance (defined as their main problematic substance use).
- Present a current diagnosis of SUD for this primary substance according to DSM-5 criteria.
Who cannot join
- Medical, psychiatric or addiction condition that warrants immediate inpatient treatment intervention.
- Somatic, cognitive or other disorders preventing the use of the smartphone device (deafness, impaired vision, illiteracy….).
- Not being familiar with the use of smartphone
- Having a smartphone not compatible with the application and being unable to visit the laboratory to receive a loaner phone for the study.
- Difficulty in understanding and/or writing and/or reading French.
- Individuals participating in another study that includes an ongoing exclusion period.
Show all 9Show fewer
- Be deprived of liberty due to an ongoing legal procedure.
- Be under legal protection.
- Be under guardianship or conservatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Université de Bordeaux CNRS UMR 6033 SANPSY
Bordeaux, 33000
Fuschia SERRE, Ph.D, fuschia.serre@u-bordeaux.fr
About this study
Official title: Symptom Networks Characteristics and Centrality of Craving as Markers of Transition Across Levels of Addiction Severity: A Longitudinal Study
Substance/Alcohol Use disorders are defined as a loss of control over the use despite harmul consequences, as well as an intense and persistent urge to use, also called craving. Previous research has shown that craving is central among the diagnostic criteria for addiction, suggesting that it may be important in the onset and persistence of addiction.
Addiction develops progressively, and it appears crucial to identify predictive markers of the transition from one level of severity to another over time. One hypothesis is that more closely linked symptoms (meaning symptoms that influence each other more) could be associated with greater severity and/or with the evolution of addiction severity over time.
The aim of this project is to explore how the characteristics of the association between addiction symptoms (diagnostic criteria and symptoms as they occur in daily life), and the importance of craving relative to other symptoms, could serve as markers of different addiction severities and of the transition across these levels of severity.
Read the detailed description
Exploratory analyses will assess whether craving network metrics, including craving symptom centrality, network global strength, and node predictability, are associated with participant characteristics and clinical measures. Potential predictors and correlates will include sociodemographic characteristics, addiction type and history, psychiatric comorbidities, addiction severity, cognitive performance, personality traits, insight, interoceptive awareness, anxiety and depressive symptoms, childhood trauma, and quality of life. These variables will be assessed using age and sex data, addiction history variables, the Mini International Neuropsychiatric Interview, Addiction Severity Index, Montreal Cognitive Assessment, Iowa Gambling Task, Stroop task, UPPS-P Impulsive Behavior Scale, Sensation Seeking Scale, Temperament and Character Inventory, HAIS-m, MAIA-2, Beck Anxiety Inventory, Beck Depression Inventory, Childhood Trauma Questionnaire-Short Form, and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. Associations will be explored using correlation and regression analyses, as appropriate to the distribution and measurement level of each variable, at baseline and at the 1-year and 2-year follow-ups.
- Conditions
- Addiction
- Being tested
- Observational assessments (EMA and annual DSM-5 evaluations)
- Keywords
- Substance Use Disorder, Addiction, Symptoms network, Ecological Momentary Assessment, Trajectory, Staging
- Medical subject headings
- Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessments (EMA and annual DSM-5 evaluations)Other
Participants are observed over two years. Annual DSM-5 diagnostic criteria for substance use disorders (SUD) are assessed, and participants complete 2-week EMA protocols measuring substance use, craving, and related factors four times per day. No intervention is administered.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol | Participants with various level of Alcohol Use Disorder severity Receives: Other: Observational assessments (EMA and annual DSM-5 evaluations) | |
| Tobacco | Participants with various level of Tobacco Use Disorder severity Receives: Other: Observational assessments (EMA and annual DSM-5 evaluations) | |
| Cannabis | Participants with various level of CannabisUse Disorder severity Receives: Other: Observational assessments (EMA and annual DSM-5 evaluations) | |
| Opiates | Participants with various level of Opiates Use Disorder severity. Receives: Other: Observational assessments (EMA and annual DSM-5 evaluations) | |
| Stimulants | Participants with various level of Stimulant Use Disorder severity Receives: Other: Observational assessments (EMA and annual DSM-5 evaluations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving centrality in the DSM-5 Substance Use Disorder diagnostic criteria network
Craving centrality will be quantified as the expected influence centrality of the DSM-5 craving criterion within a cross-sectional network including the 11 DSM-5 Substance Use Disorder diagnostic criteria. Expected influence values will be estimated for each assessment (baseline, 1-year and 2-year follow-up) and compared across addiction severity groups and severity transition groups.
Measured: Baseline, 1-year follow-up, 2-year follow-up
Global connectivity of the DSM-5 Substance Use Disorder diagnostic criteria network
Global network connectivity will be quantified as global strength (sum of absolute edge weights) of the DSM-5 diagnostic criteria network. Global strength estimates will be compared across addiction severity groups and severity transition groups.
Measured: Baseline, 1-year follow-up, 2-year follow-up
Predictability of nodes in the DSM-5 Substance Use Disorder diagnostic criteria network
Node predictability will be calculated as the proportion of variance explained (R²) for each DSM-5 diagnostic criterion by its neighboring nodes within the network. Mean node predictability will be reported and compared across addiction severity groups and severity transition groups.
Measured: Baseline, 1-year follow-up, 2-year follow-up
Differences in DSM-5 Substance Use Disorder diagnostic criteria network structure
Differences in overall network structure and global strength between addiction severity groups and severity transition groups will be evaluated using the Network Comparison Test (NCT). The reported outcome will be the statistical significance of differences in network structure.
Measured: Baseline, 1-year follow-up, 2-year follow-up
Temporal network structure of ecological momentary assessment (EMA) symptoms
Temporal directed network parameters estimated from ecological momentary assessment data including primary substance use, craving, affect, self-efficacy, withdrawal symptoms, cues, stress, coping, sleep, impulsivity and other daily-life variables. Temporal edge weights will be estimated using multilevel vector autoregressive models and compared across severity groups and severity transition groups.
Measured: Baseline, 1-year follow-up, 2-year follow-up
Contemporaneous network structure of ecological momentary assessment (EMA) symptoms
Contemporaneous partial correlation network estimated from ecological momentary assessment variables. Network structure will be compared across severity groups and severity transition groups.
Measured: Baseline, 1-year follow-up, 2-year follow-up
Between-subject network structure of ecological momentary assessment (EMA) symptoms
Between-subject partial correlation network estimated from ecological momentary assessment variables. Network structure will be compared across severity groups and severity transition groups.
Measured: Baseline, 1-year follow-up, 2-year follow-up
Individual network invariance assessed by the Individual Network Invariance Test (INIT)
Individual Network Invariance Test (INIT) results will assess whether each participant's symptom network significantly differs from the group-level network. The proportion of significant INIT tests will be reported and compared across severity groups.
Measured: Baseline, 1-year follow-up, 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start20 May 2026
- Primary completionDec 2030 (estimated)
- Study completionJun 2031 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Fuschia SERRE, Principal investigator, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734363
- Sponsor's protocol ID
- 26.00741.000491
- Other IDs
- 2026-A00034-47
- Acronym
- CARDEMA
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be available upon reasonable request to the principal investigator. Access will be granted to researchers who provide a methodologically sound proposal for achieving the aims of the approved proposal. A data access agreement may be required before the data are released.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Networks Characteristics and Centrality of Craving as Markers of Transition Across Levels of Addiction Severity: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT07734363
- Acronym / sponsor ID
- CARDEMA / 26.00741.000491
- Conditions
- Addiction
- Keywords
- Substance Use Disorder, Addiction, Symptoms network, Ecological Momentary Assessment, Trajectory, Staging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 20 May 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 29 Jul 2026 (actual)
- 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.
Substance/Alcohol Use disorders are defined as a loss of control over the use despite harmul consequences, as well as an intense and persistent urge to use, also called craving. Previous research has shown that craving is central among the diagnostic criteria for addiction, suggesting that it may be important in the onset and persistence of addiction.
Addiction develops progressively, and it appears crucial to identify predictive markers of the transition from one level of severity to another over time. One hypothesis is that more closely linked symptoms (meaning symptoms that influence each other more) could be associated with greater severity and/or with the evolution of addiction severity over time.
The aim of this project is to explore how the characteristics of the association between addiction symptoms (diagnostic criteria and symptoms as they occur in daily life), and the importance of craving relative to other symptoms, could serve as markers of different addiction severities and of the transition across these levels of severity.
Detailed description
Exploratory analyses will assess whether craving network metrics, including craving symptom centrality, network global strength, and node predictability, are associated with participant characteristics and clinical measures. Potential predictors and correlates will include sociodemographic characteristics, addiction type and history, psychiatric comorbidities, addiction severity, cognitive performance, personality traits, insight, interoceptive awareness, anxiety and depressive symptoms, childhood trauma, and quality of life. These variables will be assessed using age and sex data, addiction history variables, the Mini International Neuropsychiatric Interview, Addiction Severity Index, Montreal Cognitive Assessment, Iowa Gambling Task, Stroop task, UPPS-P Impulsive Behavior Scale, Sensation Seeking Scale, Temperament and Character Inventory, HAIS-m, MAIA-2, Beck Anxiety Inventory, Beck Depression Inventory, Childhood Trauma Questionnaire-Short Form, and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. Associations will be explored using correlation and regression analyses, as appropriate to the distribution and measurement level of each variable, at baseline and at the 1-year and 2-year follow-ups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Alcohol | – | Other: Observational assessments (EMA and annual DSM-5 evaluations)Participants with various level of Alcohol Use Disorder severity |
| Tobacco | – | Other: Observational assessments (EMA and annual DSM-5 evaluations)Participants with various level of Tobacco Use Disorder severity |
| Cannabis | – | Other: Observational assessments (EMA and annual DSM-5 evaluations)Participants with various level of CannabisUse Disorder severity |
| Opiates | – | Other: Observational assessments (EMA and annual DSM-5 evaluations)Participants with various level of Opiates Use Disorder severity. |
| Stimulants | – | Other: Observational assessments (EMA and annual DSM-5 evaluations)Participants with various level of Stimulant Use Disorder severity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have initiated treatment for addiction in a Centre de Soin et d'Accompagnement et de Prévention en Addictologie in France; People with addiction recruited from the general population via recruitment campaigns (posters, partner institutions websites, newspaper, social media); Users of Kanopée, a smartphone application developed by SANPSY Lab, who reported problematic tobacco, alcohol or cannabis use.
Key inclusion criteria (4 listed)
- Be over 18 years of age
- Identify a primary substance as a main problematic substance use.
- Be a regular user (at least twice a week in the last 30 days) of a primary substance (defined as their main problematic substance use).
- Present a current diagnosis of SUD for this primary substance according to DSM-5 criteria.
Key exclusion criteria (9 listed)
- Medical, psychiatric or addiction condition that warrants immediate inpatient treatment intervention.
- Somatic, cognitive or other disorders preventing the use of the smartphone device (deafness, impaired vision, illiteracy….).
- Not being familiar with the use of smartphone
- Having a smartphone not compatible with the application and being unable to visit the laboratory to receive a loaner phone for the study.
- Difficulty in understanding and/or writing and/or reading French.
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 |
|---|---|---|
| Observational assessments (EMA and annual DSM-5 evaluations)Participants are observed over two years. Annual DSM-5 diagnostic criteria for substance use disorders (SUD) are assessed, and participants complete 2-week EMA protocols measuring substance use, craving, and related factors four times per day. No intervention is administered. | Other | Alcohol, Cannabis, Opiates, Stimulants, Tobacco |
Primary outcome
Craving centrality in the DSM-5 Substance Use Disorder diagnostic criteria network
Time frame: Baseline, 1-year follow-up, 2-year follow-up
Craving centrality will be quantified as the expected influence centrality of the DSM-5 craving criterion within a cross-sectional network including the 11 DSM-5 Substance Use Disorder diagnostic criteria. Expected influence values will be estimated for each assessment (baseline, 1-year and 2-year follow-up) and compared across addiction severity groups and severity transition groups.
Global connectivity of the DSM-5 Substance Use Disorder diagnostic criteria network
Time frame: Baseline, 1-year follow-up, 2-year follow-up
Global network connectivity will be quantified as global strength (sum of absolute edge weights) of the DSM-5 diagnostic criteria network. Global strength estimates will be compared across addiction severity groups and severity transition groups.
Predictability of nodes in the DSM-5 Substance Use Disorder diagnostic criteria network
Time frame: Baseline, 1-year follow-up, 2-year follow-up
Node predictability will be calculated as the proportion of variance explained (R²) for each DSM-5 diagnostic criterion by its neighboring nodes within the network. Mean node predictability will be reported and compared across addiction severity groups and severity transition groups.
Differences in DSM-5 Substance Use Disorder diagnostic criteria network structure
Time frame: Baseline, 1-year follow-up, 2-year follow-up
Differences in overall network structure and global strength between addiction severity groups and severity transition groups will be evaluated using the Network Comparison Test (NCT). The reported outcome will be the statistical significance of differences in network structure.
Temporal network structure of ecological momentary assessment (EMA) symptoms
Time frame: Baseline, 1-year follow-up, 2-year follow-up
Temporal directed network parameters estimated from ecological momentary assessment data including primary substance use, craving, affect, self-efficacy, withdrawal symptoms, cues, stress, coping, sleep, impulsivity and other daily-life variables. Temporal edge weights will be estimated using multilevel vector autoregressive models and compared across severity groups and severity transition groups.
Contemporaneous network structure of ecological momentary assessment (EMA) symptoms
Time frame: Baseline, 1-year follow-up, 2-year follow-up
Contemporaneous partial correlation network estimated from ecological momentary assessment variables. Network structure will be compared across severity groups and severity transition groups.
Between-subject network structure of ecological momentary assessment (EMA) symptoms
Time frame: Baseline, 1-year follow-up, 2-year follow-up
Between-subject partial correlation network estimated from ecological momentary assessment variables. Network structure will be compared across severity groups and severity transition groups.
Individual network invariance assessed by the Individual Network Invariance Test (INIT)
Time frame: Baseline, 1-year follow-up, 2-year follow-up
Individual Network Invariance Test (INIT) results will assess whether each participant's symptom network significantly differs from the group-level network. The proportion of significant INIT tests will be reported and compared across severity groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be available upon reasonable request to the principal investigator. Access will be granted to researchers who provide a methodologically sound proposal for achieving the aims of the approved proposal. A data access agreement may be required before the data are released.
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.
Fuschia SERRE principal investigator
University of Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addiction, run by University of Bordeaux at 1 site 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuschia SERRE, Ph-D (+33 05 56 56 17 38, fuschia.serre@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving centrality in the DSM-5 Substance Use Disorder diagnostic criteria network (time frame: Baseline, 1-year follow-up, 2-year follow-up). The study lists 8 primary outcomes in all. 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 29 Jul 2026.