Clinical trial NCT04732676: Efficacy of a Smartphone App. Designed to Manage Craving & Individual Predictors of Substance Use/Addictive Behavior
Official title: Efficacy of a Smartphone App Designed to Manage Craving and Individual Predictors of Substance Use / Addictive Behavior Among Individuals With Addictive Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Addiction
Keywords: craving
Lead sponsor: Centre Hospitalier Charles Perrens, Bordeaux
Sponsor class: OTHER_GOV
First posted: 2021-02-01
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled trial comparing two parallel groups. This is a comparative study of superiority that evaluates the efficacy of using an interventional smartphone application,in reducing main problematic substance use/addictive behavior after 4 weeks, and after 4 months among participants requesting treatment for substance or behavioral addiction.
Primary purpose: OTHER

Brief summary: Test the Efficacy of a smartphone application designed to manage craving and individual predictors of substance use / addictive behavior among individuals with addictive disorders

Detailed description: This translational project is the clinical application of research results from the University of Bordeaux, Sanpsy Lab, CNRS USR3413 - on individual predictors of substance use. This project will test the efficacy of a smartphone application to help subjects concerned about reducing or stopping their substance use / behavioral addiction. This new therapeutic tool, designed by University of Bordeaux, Sanpsy Lab, CNRS USR3413 - to manage craving and individual predictors of use, will offer the possibility of an easy to-use and personalized intervention accessible to the greatest number of subjects. Based on our previous results that supports that, for all types of addiction, craving and individual cues are a significant drive for use in people with addiction, the application tested in this study was designed to be used among people presenting various types of addiction (substance and behavioral addictions). The application will also evaluate all concurrent substance uses and addictive behaviors to identify and prevent risk of addiction transfers.

Eligibility criteria: Inclusion Criteria:

* Participants requesting help for substance or behavioral addiction in one of the participating specialized addiction treatment centers, and with more than 1-month-delay before treatment admission
* Age \>= 18 years of age
* With at least one substance or behavioral addiction (DSM-5 criteria)
* Affiliated person or beneficiary of a social security scheme.
* Free, informed and written consent signed by the participant and the investigator

Exclusion Criteria:

* Medical, psychiatric or addiction condition that warrants immediate treatment intervention
* Patients with somatic, cognitive or other disorders preventing the use of the device (deafness, impaired vision, illiteracy....)
* Difficulty in understanding and / or writing French
* Not familiar with the use of smartphone
* Individuals participating in another study that includes an ongoing exclusion period
* Be deprived of liberty due to an ongoing legal procedure
* Individuals under legal protection
* Be under guardianship or under curatorship

Primary outcomes:
measure: The decrease of main problematic substance use / addictive behavior
timeFrame: 4 weeks
Secondary outcomes:
measure: Efficacy of the intervention in reduction on addiction severity (ASI) and craving for primary addiction,
timeFrame: At 1-month and 4-month follow-up
measure: Factors associated with application efficacy among initial addiction severity (ASI), initial craving for primary addiction, type of primary addiction, comorbid psychiatric disorders (MINI), and addiction treatment (ASI and TSR)
timeFrame: inclusion
measure: Temporal evolution of craving and substance use/addictive behaviors The evolution and temporal trajectories of craving intensity, substances use/addictive behaviors measured with EMA in daily life
timeFrame: 4 weeks
measure: Feasibility of the smartphone application as assessed by use of the app (EMA responses) and drop-out rates
timeFrame: at 1-month
measure: Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS
timeFrame: at 1-month
measure: Impact on subsequent standard treatment at 4-month follow -up
timeFrame: at 4-month follow-up
measure: Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS
timeFrame: at 1-mont
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Charles PERRENS
Study officials:
affiliation: Centre Hospitalier CHARLES PERRENS
name: MARC AURIACOMBE, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: