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

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ClinicalTrials.gov Identifier: NCT03606759
Recruitment Status : Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Addictive Behavior Substance-Related Disorders Procedure: Weekly assessment Procedure: Weekly assessment ajusted Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
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: Group 2
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)





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adjusted Therapy Scale (ATI) [ Time Frame: Week 1 to Week 11 ]
  2. Addiction Severity Index (ASI) [ Time Frame: Week 1 to Week 11 ]
    History and the severity of addiction

  3. Cues of each participant (QSA) [ Time Frame: Week 1 to Week 11 ]
  4. Mini International Neuropsychiatric Interview (MINI) [ Time Frame: Week 1 to Week 11 ]
    Psychiatric comorbidities



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Seek treatment for a substance use disorder or gambling disorder
  • Initiate a treatment for a substance use disorder or gambling disorder at one of the recruitment site (addiction clinic)
  • Beneficiary of the French Social Security system
  • Give an informed consent to participate

    o Exclusion criteria:

  • Severe physical or psychiatric 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606759


Contacts
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Contact: Mélina Fatseas 05 24 54 90 00 melina.fatseas@u-bordeaux.fr
Contact: Fuschia Serre 05 56 56 34 86 fuschia.serre@u-bordeaux.fr

Locations
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France
Centre de Soin d'Accompagnement et de Prévention en Addictologie (CSAPA) BIZIA Not yet recruiting
Bayonne, France, 34 100
Contact: Jean-Pierre DAULOUEDE    06 07 34 66 17    jean-pierre.daulouede@wanadoo.fr   
Bordeaux University Hospital Not yet recruiting
Bordeaux, France, 33076
Contact: Fuschia Serre    05 56 56 34 86    fuschia.serre@u-bordeaux.fr   
Centre Hospitalier Charles Perrens Not yet recruiting
Bordeaux, France, 33076
Contact: Marc AURIACOMBE    05 56 56 17 38    marc.auriacombe@u-bordeaux.fr   
Centre Hospitalier Esquirol Not yet recruiting
Limoges, France, 87 025
Contact: Philippe NUBUKPO    05 55 43 12 18    philippe.nubukpo@9online.fr   
Centre Hospitalier Universitaire La Réunion Not yet recruiting
Saint-Denis, France, 97 405
Contact: David METE    02 62 90 56 01    david.mete@chu-reunion.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Mélina Fatseas University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03606759     History of Changes
Other Study ID Numbers: CHUBX 2014/43
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Addiction
High-risk relapse situation
Craving
Individual cues
Individually tailored treatment

Additional relevant MeSH terms:
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Behavior, Addictive
Substance-Related Disorders
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders