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Recruiting NCT04732676

Efficacy of a Smartphone App. Designed to Manage Craving & Individual Predictors of Substance Use/Addictive Behavior

No phase Interventional Addiction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartphone application.
Who it may be relevant to
Registry conditions: Addiction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of a Smartphone App Designed to Manage Craving and Individual Predictors of Substance Use / Addictive Behavior Among Individuals With Addictive Disorders

Overview

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.

Interventions

  • Other Smartphone application
    Ecological Momentary Assessment (EMA) : ambulatory assessment of behaviors/symptoms in real-time on smartphones

Primary outcome measures

  • The decrease of main problematic substance use / addictive behavior [Time frame: 4 weeks]
Secondary outcome measures (7)
  • Efficacy of the intervention in reduction on addiction severity (ASI) and craving for primary addiction, [Time frame: At 1-month and 4-month follow-up]
  • 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) [Time frame: inclusion]
  • 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 [Time frame: 4 weeks]
  • Feasibility of the smartphone application as assessed by use of the app (EMA responses) and drop-out rates [Time frame: at 1-month]
  • Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS [Time frame: at 1-month]
  • Impact on subsequent standard treatment at 4-month follow -up [Time frame: at 4-month follow-up]
  • Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS [Time frame: at 1-mont]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

France · 1 center
  • Centre Hospitalier Charles PERRENS — Bordeaux

Publications

  • Serre F, Moriceau S, Donnadieu L, Forcier C, Garnier H, Alexandre JM, Dupuy L, Philip P, Levavasseur Y, De Sevin E, Auriacombe M; for Craving-Manager RCT investigator group. The Craving-Manager smartphone app designed to diagnose substance use/addictive disorders, and manage craving and individual predictors of relapse: a study protocol for a multicenter randomized controlled trial. Front Psychiat PMID 37255691

Identifiers

NCT: NCT04732676 · 2020-A01707-32

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗