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

NCT ID: NCT03606759

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2023-08-01

Brief Summary

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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

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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

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Addictive Behavior Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Traitment as usual adjusted on ATI information

Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.

Group Type EXPERIMENTAL

Weekly assessment ajusted

Intervention Type PROCEDURE

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)

Traitment as usual

Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.

Group Type ACTIVE_COMPARATOR

Weekly assessment

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type 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)

Intervention Type PROCEDURE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mélina Fatseas

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Bordeaux University Hospital

Bordeaux, , France

Site Status

Centre Hospitalier Charles Perrens

Bordeaux, , France

Site Status

Centre Hospitalier Esquirol

Limoges, , France

Site Status

Centre Hospitalier Universitaire La Réunion

Saint-Denis, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2014/43

Identifier Type: -

Identifier Source: org_study_id

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