NCT06140472

Brief Summary

The objective of this study is to evaluate the effectiveness of the addition of nursing follow-up and the PHOENIX application, a personalized and self-adaptive Smartphone application, on the management of craving in patients with addictive disorders followed on an outpatient basis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 11, 2019

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 20, 2023

Status Verified

November 1, 2023

Enrollment Period

4.1 years

First QC Date

September 27, 2019

Last Update Submit

November 17, 2023

Conditions

Craving

Keywords

AddictionCravingMobile applicationCraving management

Outcome Measures

Primary Outcomes (1)

  • median craving intensity at 6 months

    Measurement of craving intensity with an analog visual scale (AVS) between 0 (no craving) and 10 (maximum imaginable craving), informed during craving episodes by the patient via the PHOENIX application or the electronic journal. Over the last 30 days before the visit at 6 months

    6 months visit

Secondary Outcomes (18)

  • Number of cravings

    0,3,6 and 12 months visit

  • Daily frequency of cravings

    0,3,6 and 12 months

  • Median of the intensity of the cravings

    0, 3, and 12 months visit

  • Number of addictive behavioural episodes

    0,3,6 and 12 months

  • Frequency of addictive behavioural episodes

    0,3,6 and 12 months

  • +13 more secondary outcomes

Study Arms (2)

Phoenix application

ACTIVE COMPARATOR

Specific individualized nurse follow-up using the PHOENIX application.

Behavioral: Phoenix

Journal de bord

SHAM COMPARATOR

Regular nursing follow-up, with the use of an electronic journal.

Behavioral: Journal de bord

Interventions

PhoenixBEHAVIORAL

Specific individualized nurse follow-up using the PHOENIX application.

Phoenix application
Journal de bordBEHAVIORAL

Regular nursing follow-up, with the use of an electronic journal.

Journal de bord

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 and 65 years old, any sex
  • Speak and read French
  • Have a Smartphone (Android operating system or IOS)
  • Present an evaluated addictive disorder in a structured clinical interview (MINI, adapted to the criteria of DSM-5: substance use disorder according to DSM-5 and bulimia nervosa; National Opinion DSM Screen (NODS), adapted to the criteria of DSM-5: pathological gambling; NODS, adapted to the diagnostic criteria proposed by Carnes: sexual addiction ; MINI)
  • Be followed on an outpatient basis
  • Prior informed written consent of the patient or his or her legal representative
  • Benefit from a French social protection system

You may not qualify if:

  • Have a current untreated and/or unstabilized psychiatric disorder (assessed by MINI)
  • Have a severe cognitive impairment assessed during the clinical interview, which does not allow you to focus your attention or use the working memory required by the application.
  • Pregnant or breastfeeding women
  • Participant in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospices Civiles de Lyon

Lyon, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Chloe Lucet, PH

    Centre Hospitalier St Anne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Dupouy, Nurse

CONTACT

01.45.65.80.64j.dupouy@ghu-paris.fr

Stephane Geyssens, Ing

CONTACT

01.45.65.61.40s.geysens@ghu-paris.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2019

First Posted

November 20, 2023

Study Start

December 11, 2019

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

November 20, 2023

Record last verified: 2023-11

Locations

FR(2)