Addictive BehaviorAjusTNCT03606759
Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity
A study testing Weekly assessment and Weekly assessment ajusted in people with Addictive Behavior and Substance-Related Disorders, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
The management of the craving is a key element in addiction treatment as the craving is linked to the probability of relapse. Several cues could induce the craving, some generic substance-induced cues or addictive behavior-related cues (e.g. gambling-related cues), and also some more subject-specific cues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addictive Behavior, Substance-Related Disorders
- What is being tested?
- Weekly assessment and Weekly assessment ajusted
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 4 sitesFrance
- Study dates
- 31 Jul 2019to 1 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Meet DSM-5 substance use disorder diagnosis for at least one substance (alcohol, tobacco, cannabis, opiates, cocaine or any other substance) use disorder or behavioral addiction (gambling, screens, video games, food addiction, sex addiction, compulsive purchases), currently not stabilized
- Seek treatment for this a substance use disorder or behavioral addiction
- Beginning (or re-initiating) multi-month outpatient care for this disorder in one of the inclusion centres.
- Ability to identify a priority substance/behavior, as main object of treatment, in case of simultaneous treatment on several addictions
- Beneficiary of the French Social Security system
Show all 17Show fewer
- Give an informed consent to participate
- o Exclusion criteria:
- Severe physical or psychiatric or addictologic condition that prevents an outpatient treatment
- Severe physical or psychiatric condition that prevents to complete the assessment
- Addictive disorder that requires several treatment for several substance use disorder simultaneously
- Difficulty to understand and to write French
- Could not be reachable by phone
- Participate to another study that prevents to participate to another research
- Prisoner
- Person under law protection
- Person under legal guardianship
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Bordeaux University Hospital
Bordeaux, 33076
Centre Hospitalier Charles Perrens
Bordeaux, 33076
Centre Hospitalier Esquirol
Limoges, 87 025
Centre Hospitalier Universitaire La Réunion
Saint-Denis, 97 405
About this study
Official title: Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity of Patients in Treatment for a Substance Use Disorder or a Behavioral Addiction. A Multicenter Randomized Controlled Trial (AjusT)
The management of the craving is a key element in addiction treatment as the craving is linked to the probability of relapse. Several cues could induce the craving, some generic substance-induced cues or addictive behavior-related cues (e.g. gambling-related cues), and also some more subject-specific cues. The awareness of the craving intensity and its individual cues for each patient will allow the clinician to tailor a better treatment. The aim of this study is to evaluate the efficacy of a program based on an Individually Adjusted Therapy scale added to a treatment as usual for the treatment of addiction.
Read the detailed description
Addiction is one of the most prevalent psychiatric disorders in general population. In the DSM-5, substance abuse and substance dependence have been combined into a single substance use disorder and gambling disorder is now reclassified in the new substance-related and addictive disorders category. Moreover, a criterion assessing the craving has been added. The management of craving is an important focus of addiction treatment as craving is often linked to relapse. Several cues could precipitate the craving. Some of them are substance-related or gambling-related, some other are more person-specific. Recent studies have revealed that those "individual cues" are highly predictive of craving and relapse, and suggest that they are involved in addiction chronicity. The awareness of these cues and the intensity of the craving are important to tailor a better treatment adapted to the patient's need in order to prevent relapse. The aim of this study is to evaluate the efficacy of a program that includes an Individually Adjusted Therapy scale (ATI) to help the clinician to modulate the level of care regarding of the patient's risk of relapse (based on cues, intensity and frequency of the craving). The study will consist in a randomized controlled trial comparing 2 groups of participants that are seeking treatment for substance use disorder (alcohol, opiates, tobacco, cannabis, cocaine or any other substance) or behavioral addiction in an outpatient addiction clinics in France (four inclusion sites).
All the participants will be assessed with several questionnaires that evaluate the history and the severity of addiction.
- Conditions
- Addictive Behavior, Substance-Related Disorders
- Being tested
- Weekly assessment, Weekly assessment ajusted
- Keywords
- Addiction, High-risk relapse situation, Craving, Individual cues, Individually tailored treatment
- 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.
Weekly assessmentProcedure or surgery
Weekly assessment during 3 months :
Severity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours)
Weekly assessment ajustedProcedure or surgery
Weekly assessment during 3 months :
Severity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours) Individually Adjusted Therapy scale (ATI)
| Study group | Role | What they receive |
|---|---|---|
| Traitment as usual adjusted on ATI information | Experimental | Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months. Receives: Procedure: Weekly assessment ajusted |
| Traitment as usual | Active comparator | Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months. Receives: Procedure: Weekly assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving intensity (BILAN-7 jours)
Craving intensity measured by the difference in craving intensity score at baseline and 3-month follow-up
Measured: 3 month
Secondary outcomes (4)
Adjusted Therapy Scale (ATI)
Measured: Week 1 to Week 11
Addiction Severity Index (ASI)
History and the severity of addiction
Measured: Week 1 to Week 11
Cues of each participant (QSA)
Measured: Week 1 to Week 11
Mini International Neuropsychiatric Interview (MINI)
Psychiatric comorbidities
Measured: Week 1 to Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start31 Jul 2019
- Primary completion2 May 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Addictive BehaviorStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mélina Fatseas, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606759
- Sponsor's protocol ID
- CHUBX 2014/43
- Acronym
- AjusT
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Denis C, Fatseas M, Beltran V, Serre F, Alexandre JM, Debrabant R, Daulouede JP, Auriacombe M. Usefulness and validity of the modified Addiction Severity Index: A focus on alcohol, drugs, tobacco, and gambling. Subst Abus. 2016;37(1):168-75. doi: 10.1080/08897077.2015.1036334. Epub 2015 Jun 25.
PubMed 26110463
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity of Patients in Treatment for a Substance Use Disorder or a Behavioral Addiction. A Multicenter Randomized Controlled Trial (AjusT)
- ClinicalTrials.gov ID
- NCT03606759
- Acronym / sponsor ID
- AjusT / CHUBX 2014/43
- Conditions
- Addictive Behavior, Substance-Related Disorders
- Keywords
- Addiction, High-risk relapse situation, Craving, Individual cues, Individually tailored treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 31 Jul 2018 (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.
The management of the craving is a key element in addiction treatment as the craving is linked to the probability of relapse. Several cues could induce the craving, some generic substance-induced cues or addictive behavior-related cues (e.g. gambling-related cues), and also some more subject-specific cues. The awareness of the craving intensity and its individual cues for each patient will allow the clinician to tailor a better treatment. The aim of this study is to evaluate the efficacy of a program based on an Individually Adjusted Therapy scale added to a treatment as usual for the treatment of addiction.
Detailed description
Addiction is one of the most prevalent psychiatric disorders in general population. In the DSM-5, substance abuse and substance dependence have been combined into a single substance use disorder and gambling disorder is now reclassified in the new substance-related and addictive disorders category. Moreover, a criterion assessing the craving has been added. The management of craving is an important focus of addiction treatment as craving is often linked to relapse. Several cues could precipitate the craving. Some of them are substance-related or gambling-related, some other are more person-specific. Recent studies have revealed that those "individual cues" are highly predictive of craving and relapse, and suggest that they are involved in addiction chronicity. The awareness of these cues and the intensity of the craving are important to tailor a better treatment adapted to the patient's need in order to prevent relapse. The aim of this study is to evaluate the efficacy of a program that includes an Individually Adjusted Therapy scale (ATI) to help the clinician to modulate the level of care regarding of the patient's risk of relapse (based on cues, intensity and frequency of the craving). The study will consist in a randomized controlled trial comparing 2 groups of participants that are seeking treatment for substance use disorder (alcohol, opiates, tobacco, cannabis, cocaine or any other substance) or behavioral addiction in an outpatient addiction clinics in France (four inclusion sites).
All the participants will be assessed with several questionnaires that evaluate the history and the severity of addiction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traitment as usual adjusted on ATI information | Experimental | Procedure: Weekly assessment ajustedAssessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months. |
| Traitment as usual | Active comparator | Procedure: Weekly assessmentAssessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 18 years old or older
- Meet DSM-5 substance use disorder diagnosis for at least one substance (alcohol, tobacco, cannabis, opiates, cocaine or any other substance) use disorder or behavioral addiction (gambling, screens, video games, food addiction, sex addiction, compulsive purchases), currently not stabilized
- Seek treatment for this a substance use disorder or behavioral addiction
- Beginning (or re-initiating) multi-month outpatient care for this disorder in one of the inclusion centres.
- Ability to identify a priority substance/behavior, as main object of treatment, in case of simultaneous treatment on several addictions
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Weekly assessmentWeekly assessment during 3 months : Severity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours) | Procedure or surgery | Traitment as usual |
| Weekly assessment ajustedWeekly assessment during 3 months : Severity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours) Individually Adjusted Therapy scale (ATI) | Procedure or surgery | Traitment as usual adjusted on ATI information |
Primary outcome
Craving intensity (BILAN-7 jours)
Time frame: 3 month
Craving intensity measured by the difference in craving intensity score at baseline and 3-month follow-up
4 secondary outcomes
Adjusted Therapy Scale (ATI)
Time frame: Week 1 to Week 11
Addiction Severity Index (ASI)
Time frame: Week 1 to Week 11
Cues of each participant (QSA)
Time frame: Week 1 to Week 11
Mini International Neuropsychiatric Interview (MINI)
Time frame: Week 1 to Week 11
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 14 May 2026.
- Results publication: PubMed 26110463Denis C, Fatseas M, Beltran V, Serre F, Alexandre JM, Debrabant R, Daulouede JP, Auriacombe M. Usefulness and validity of the modified Addiction Severity Index: A focus on alcohol, drugs, tobacco, and gambling. Subst Abus. 2016;37(1):168-75. doi: 10.1080/08897077.2015.1036334. Epub 2015 Jun 25.
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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.
Mélina Fatseas principal investigator
University Hospital, Bordeaux
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly assessment and Weekly assessment ajusted in people with Addictive Behavior and Substance-Related Disorders, run by University Hospital, Bordeaux at 4 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 17 inclusion and 0 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Craving intensity (BILAN-7 jours) (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606759, which also lists 1 linked publication.
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 14 May 2026.