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

NCT04732676 | Recruiting

• 1 other identifier: 2020-A01707-32
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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

Conditions

Addiction

Keywords

craving

Outcome Measures

Primary Outcomes (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

  4 weeks

Secondary Outcomes (7)

• Efficacy of the intervention in reduction on addiction severity (ASI) and craving for primary addiction,

  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)

  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

  4 weeks

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

  at 1-month

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

  at 1-month

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Smartphone application

control group

PLACEBO 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

Other: Smartphone application

Interventions

Smartphone application OTHER

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

Experimental group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Be deprived of liberty due to an ongoing legal procedure
• Individuals under legal protection
• Be under guardianship or under curatorship

Sponsors & Collaborators

• Centre Hospitalier Charles Perrens, Bordeaux: lead

Study Sites (1)

Centre Hospitalier Charles PERRENS

Bordeaux, 33076, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 37255691 DERIVED

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• MARC AURIACOMBE, MD, Prof

  Centre Hospitalier CHARLES PERRENS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: February 1, 2021
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)