Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity (AjusT)
Primary Purpose
Addictive Behavior, Substance-Related Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Weekly assessment
Weekly assessment ajusted
Sponsored by
About this trial
This is an interventional supportive care trial for Addictive Behavior focused on measuring Addiction, High-risk relapse situation, Craving, Individual cues, Individually tailored treatment
Eligibility Criteria
Inclusion criteria:
- 18 years old or older
- Meet DSM-5 substance use disorder diagnosis for at least one substance (alcohol, tobacco, cannabis, opiates, cocaine) or gambling disorder currently not stabilized
- Seek treatment for this a substance use disorder or gambling disorder
- 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
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
Sites / Locations
- Centre de Soin d'Accompagnement et de Prévention en Addictologie (CSAPA) BIZIA
- Bordeaux University Hospital
- Centre Hospitalier Charles PerrensRecruiting
- Centre Hospitalier Esquirol
- Centre Hospitalier Universitaire La Réunion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Traitment as usual adjusted on ATI information
Traitment as usual
Arm Description
Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.
Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.
Outcomes
Primary Outcome Measures
Craving intensity (BILAN-7 jours)
Craving intensity measured by the difference in craving intensity score at baseline and 3-month follow-up
Secondary Outcome Measures
Adjusted Therapy Scale (ATI)
Addiction Severity Index (ASI)
History and the severity of addiction
Cues of each participant (QSA)
Mini International Neuropsychiatric Interview (MINI)
Psychiatric comorbidities
Full Information
NCT ID
NCT03606759
First Posted
July 20, 2018
Last Updated
March 30, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT03606759
Brief Title
Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity
Acronym
AjusT
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 Gambling Disorder. A Multicenter Randomized Controlled Trial (AjusT)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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 gambling disorder 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addictive Behavior, Substance-Related Disorders
Keywords
Addiction, High-risk relapse situation, Craving, Individual cues, Individually tailored treatment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traitment as usual adjusted on ATI information
Arm Type
Experimental
Arm Description
Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.
Arm Title
Traitment as usual
Arm Type
Active Comparator
Arm Description
Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.
Intervention Type
Procedure
Intervention Name(s)
Weekly assessment
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Weekly assessment ajusted
Intervention Description
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)
Primary Outcome Measure Information:
Title
Craving intensity (BILAN-7 jours)
Description
Craving intensity measured by the difference in craving intensity score at baseline and 3-month follow-up
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Adjusted Therapy Scale (ATI)
Time Frame
Week 1 to Week 11
Title
Addiction Severity Index (ASI)
Description
History and the severity of addiction
Time Frame
Week 1 to Week 11
Title
Cues of each participant (QSA)
Time Frame
Week 1 to Week 11
Title
Mini International Neuropsychiatric Interview (MINI)
Description
Psychiatric comorbidities
Time Frame
Week 1 to Week 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
18 years old or older
Meet DSM-5 substance use disorder diagnosis for at least one substance (alcohol, tobacco, cannabis, opiates, cocaine) or gambling disorder currently not stabilized
Seek treatment for this a substance use disorder or gambling disorder
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mélina Fatseas
Phone
05 24 54 90 00
Email
melina.fatseas@u-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fuschia Serre
Phone
05 56 56 34 86
Email
fuschia.serre@u-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mélina Fatseas
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Soin d'Accompagnement et de Prévention en Addictologie (CSAPA) BIZIA
City
Bayonne
ZIP/Postal Code
34 100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre DAULOUEDE
Phone
06 07 34 66 17
Email
jean-pierre.daulouede@wanadoo.fr
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuschia Serre
Phone
05 56 56 34 86
Email
fuschia.serre@u-bordeaux.fr
Facility Name
Centre Hospitalier Charles Perrens
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc AURIACOMBE
Phone
05 56 56 17 38
Email
marc.auriacombe@u-bordeaux.fr
Facility Name
Centre Hospitalier Esquirol
City
Limoges
ZIP/Postal Code
87 025
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe NUBUKPO
Phone
05 55 43 12 18
Email
philippe.nubukpo@9online.fr
Facility Name
Centre Hospitalier Universitaire La Réunion
City
Saint-Denis
ZIP/Postal Code
97 405
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David METE
Phone
02 62 90 56 01
Email
david.mete@chu-reunion.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity
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