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

NCT ID: NCT04732676

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2028-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Addiction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
After randomization, the application will be installed on participant's smartphone (or smartphone loaned for the study).

Randomization code will unlock one of the 2 versions of the application:

* Restricted version (only EMA) for control group
* Full interventional (active) version (EMA + EMI) for experimental group

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

participants will receive and use during 4 weeks the full interventional version of the smartphone application (combining EMA + EMI) targeting craving and personal situations at risk for use

Group Type EXPERIMENTAL

Smartphone application

Intervention Type OTHER

Ecological Momentary Assessment (EMA)

: ambulatory assessment of behaviors/symptoms in real-time on smartphones

control group

: participants will receive and use a restricted version of the smartphone application (only EMA: 4 electronic questionnaires per day to assess main problematic substance use / addictive behavior) during 4 weeks

Group Type PLACEBO_COMPARATOR

Smartphone application

Intervention Type OTHER

Ecological Momentary Assessment (EMA)

: ambulatory assessment of behaviors/symptoms in real-time on smartphones

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Smartphone application

Ecological Momentary Assessment (EMA)

: ambulatory assessment of behaviors/symptoms in real-time on smartphones

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Charles Perrens, Bordeaux

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MARC AURIACOMBE, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier CHARLES PERRENS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Charles PERRENS

Bordeaux, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

MARC AURIACOMBE, MD, Prof

Role: CONTACT

05 56 56 17 38

AURELIEN VAUTARD

Role: CONTACT

05 56 56 34 00

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

MARC AURIACOMBE, MD, Prof

Role: primary

05 56 56 17 38

References

Explore related publications, articles, or registry entries linked to this study.

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 Psychiatry. 2023 May 15;14:1143167. doi: 10.3389/fpsyt.2023.1143167. eCollection 2023.

Reference Type DERIVED
PMID: 37255691 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A01707-32

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Coaching for HCV and HIV
NCT04314414 COMPLETED NA
OUD Smartphone Services
NCT06134882 RECRUITING NA
Buprenorphine for Prisoners
NCT00574067 COMPLETED PHASE3
Smartphones for Opiate Addiction Recovery
NCT05033028 RECRUITING PHASE3