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AddictionCRAVINGMANAGERNCT04732676

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

A study testing Smartphone application in people with Addiction, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Addiction
What is being tested?
Smartphone application
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
274 participants
Where
1 siteFrance
Study dates
1 Mar 2023to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

MARC AURIACOMBE, MD, Prof contact

05 56 56 17 38

mauriacombe@ch-perrens.fr

AURELIEN VAUTARD contact

05 56 56 34 00

avautard@ch-perrens.fr

France1 site, 1 recruiting
  • Centre Hospitalier Charles PERRENS

    Bordeaux, 33076

    MARC AURIACOMBE, MD, Prof, 05 56 56 17 38, mauriacombe@ch-perrens.fr

    Recruiting

Other trials in France

About this study

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

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

Read the 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.

Conditions
Addiction
Being tested
Smartphone application
Keywords
craving
Medical subject headings
Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartphone applicationOther

    Ecological Momentary Assessment (EMA)

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

Study groups in NCT04732676
Study groupRoleWhat they receive
Experimental groupExperimentalparticipants 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
Receives: Other: Smartphone application
control groupPlacebo comparator: 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
Receives: Other: Smartphone application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The decrease of main problematic substance use / addictive behavior

    We will compare the percentage of participants for whom a 20% decrease in main problematic substance use / addictive behavior was observed between 1st week and 4 th week of smartphone application use in the experimental group versus the control group

    Measured: 4 weeks

Secondary outcomes (7)
  1. Efficacy of the intervention in reduction on addiction severity (ASI) and craving for primary addiction,

    Multifactorial addiction severity ASI "Composite Score" for the main problematic addiction (drug or alcohol or tobacco or behavioral addiction) : Range 0-1 (1: higher severity) and craving self-reported in the last EMA week, and reported in the Craving evaluation scale developed by the University of Bordeaux Addiction Team of the Sanpsy Laboratory will be used. It is an heteroevaluation of craving for all substances and addictive behaviors reported by the subject. This tool explores the frequency of craving, corresponding to the number of days craving was reported during the last 30 days, as well as mean and maximum intensity on a scale ranging from 0 (no craving) to 10 (extreme craving).

    Comparison between baseline, 1-month et 4-month follow-ups of frequency, mean and maximum intensity of craving for main problematic addiction

    Measured: At 1-month and 4-month follow-up

  2. 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)

    Evaluation of the initial severity of addiction ASI "Composite Score" for the main problematic addiction (drug or alcohol or tobacco or behavioral addiction) : Range 0-1 (1: higher severity), initial craving frequency and intensity with craving evaluation scale, the type of addiction,comorbid psychiatric disorders (evaluated with Mini International Neuropsychiatric Interview), and past or concomitant addiction treatment (evaluated by ASI and Treatment Service Review).

    Measured: inclusion

  3. 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

    During the 4 weeks use of the application, all participants will be instructed to complete 4 daily EMA electronic interviews to assess craving-and substance use/addictive behavior (see Serre, Fatseas et al. 2012). At each electronic interview, participants will be asked to rate the maximum level of craving (i.e. the desire to use the main substance/addictive behavior) that they felt since the previous assessment on a seven-point scale (1 no desire to 7 extreme desire), and will also be asked if they had used, since the previous assessment, the main substance/addictive(yes/no)

    • The evolution and temporal trajectories of substances use/addictive behaviors measured with EMA in daily life

    Measured: 4 weeks

  4. Feasibility of the smartphone application as assessed by use of the app (EMA responses) and drop-out rates

    Feasibility will be assessed at the 1-month follow-up by number of days and frequency of use of the application (calculated from EMA responses: number of questionnaires answered on total number of questionnaires proposed by the application), rate of participants not completing the study, and reasons for stopping

    Measured: at 1-month

  5. Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS

    Acceptability will be assessed at 1-month follow-up with AES, D-WAI and uMARS. The Acceptability E-scale (AES) is a 6-item questionnaire that evaluates the extent to which subjects find E-health systems acceptable. Each item is ranked on a 5-point Likert scale, generating a total score of acceptability ranging from 6 (lowest acceptability) to 30 (highest acceptability) (Micoulaud-Franchi, Sauteraud et al. 2016). The Digital Working Alliance Inventory (D-WAI) measures factors (goals, tasks and bond) to examine the therapeutic relationship between the participant and the app (Henson et al., 2019). The user version of the Mobile Application Rating Scale (uMARS) is a simple tool that can be reliably used by end-users to assess the quality of mHealth apps (Stoyanov et al., 2016).

    Measured: at 1-month

  6. Impact on subsequent standard treatment at 4-month follow -up

    Impact of the 4 weeks use of the smartphone application Potential impact (positive or negative) of the 4 weeks use of the smartphone application on subsequent treatment will be assessed at 4-month follow-up with rate of first-time attendance to the standard treatment, time to first-time attendance to the standard treatment, compliance with standard treatment (Treatment Service Review), and evolution of severity of addiction during the standard treatment (ASI Composite Score). Follow-ups measures will be compared to baseline measures, and the difference will be compared between the two groups.

    Measured: at 4-month follow-up

  7. Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS

    Intervention Satisfaction will be assessed at 1-month follow-up with the Client Satisfaction Questionnaire (CSQ-8), that is a multi-item measure of satisfaction related to healthcare (Larsen et al., 1979; Kapp et al., 2014). The CSQ-8 total score ranges from 8 to 32. A higher score represents greater satisfaction

    Measured: at 1-mont

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2021
  2. Study start1 Mar 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
274 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04732676
Sponsor's protocol ID
2020-A01707-32
Acronym
CRAVINGMANAGER
Status last verified
Aug 2025
First submitted
10 May 2019
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

    PubMed 37255691

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone application in people with Addiction, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MARC AURIACOMBE, MD, Prof (05 56 56 17 38, mauriacombe@ch-perrens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The decrease of main problematic substance use / addictive behavior (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04732676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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