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

March 30, 2022 updated by: University Hospital, Bordeaux

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)

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

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

484

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bayonne, France, 34 100
        • Not yet recruiting
        • Centre de Soin d'Accompagnement et de Prévention en Addictologie (CSAPA) BIZIA
        • Contact:
      • Bordeaux, France, 33076
      • Bordeaux, France, 33076
        • Not yet recruiting
        • Bordeaux university hospital
        • Contact:
      • Limoges, France, 87 025
        • Not yet recruiting
        • Centre Hospitalier Esquirol
        • Contact:
      • Saint-Denis, France, 97 405
        • Not yet recruiting
        • Centre Hospitalier Universitaire La Réunion
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 3 month
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)
Time Frame: Week 1 to Week 11
Week 1 to Week 11
Addiction Severity Index (ASI)
Time Frame: Week 1 to Week 11
History and the severity of addiction
Week 1 to Week 11
Cues of each participant (QSA)
Time Frame: Week 1 to Week 11
Week 1 to Week 11
Mini International Neuropsychiatric Interview (MINI)
Time Frame: Week 1 to Week 11
Psychiatric comorbidities
Week 1 to Week 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2019

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

April 30, 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)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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