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

Substance-Related Disorders Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03606759
• Other study ID #: CHUBX 2014/43
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: Mélina Fatseas
• Phone: 05 24 54 90 00
• Email: melina.fatseas[@]u-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 484
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Addictive Behavior
• Behavior, Addictive
• Substance-Related Disorders

Intervention

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)
• 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)

Locations

Country	Name	City	State
France	Centre de Soin d'Accompagnement et de Prévention en Addictologie (CSAPA) BIZIA	Bayonne
France	Bordeaux University Hospital	Bordeaux
France	Centre Hospitalier Charles Perrens	Bordeaux
France	Centre Hospitalier Esquirol	Limoges
France	Centre Hospitalier Universitaire La Réunion	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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