Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity (AjusT)

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Addictive Behavior
• Intervention / Treatment: Procedure: Weekly assessment ajusted; Procedure: Weekly assessment

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 Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Centre Hospitalier Charles Perrens
  • Bordeaux, France, 33076
    • Bordeaux University Hospital
  • Limoges, France, 87 025
    • Centre Hospitalier Esquirol
  • Saint-Denis, France, 97 405
    • Centre Hospitalier Universitaire La Reunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traitment as usual adjusted on ATI information; Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.	Procedure: Weekly assessment ajusted; 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)
Active Comparator: Traitment as usual; Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.	Procedure: Weekly assessment; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving intensity (BILAN-7 jours)	Craving intensity measured by the difference in craving intensity score at baseline and 3-month follow-up	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Therapy Scale (ATI)		Week 1 to Week 11
Addiction Severity Index (ASI)	History and the severity of addiction	Week 1 to Week 11
Cues of each participant (QSA)		Week 1 to Week 11
Mini International Neuropsychiatric Interview (MINI)	Psychiatric comorbidities	Week 1 to Week 11

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Mélina FATSEAS, University Hospital, Bordeaux

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Addiction; Craving; High-risk relapse situation; Individual cues; Individually tailored treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Substance-Related Disorders; Behavior, Addictive
• Other Study ID Numbers: CHUBX 2014/43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No