Clinical trial NCT03606759: Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addictive Behavior
Substance-Related Disorders
Keywords: Addiction
High-risk relapse situation
Craving
Individual cues
Individually tailored treatment
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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 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

Primary outcomes:
measure: Craving intensity (BILAN-7 jours)
timeFrame: 3 month
Secondary outcomes:
measure: Adjusted Therapy Scale (ATI)
timeFrame: Week 1 to Week 11
measure: Addiction Severity Index (ASI)
timeFrame: Week 1 to Week 11
measure: Cues of each participant (QSA)
timeFrame: Week 1 to Week 11
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: Week 1 to Week 11
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Centre de Soin d'Accompagnement et de Prévention en Addictologie (CSAPA) BIZIA
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Bordeaux
country: France
facility: Centre Hospitalier Charles Perrens
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
city: Saint-Denis
country: France
facility: Centre Hospitalier Universitaire La Réunion
Study officials:
affiliation: University Hospital, Bordeaux
name: Mélina Fatseas
role: PRINCIPAL_INVESTIGATOR
References: