NCT03606759

Brief Summary

The management of the craving is a key element in addiction treatment as the craving is linked to the probability of relapse. Several cues could induce the craving, some generic substance-induced cues or addictive behavior-related cues (e.g. gambling-related cues), and also some more subject-specific cues. The awareness of the craving intensity and its individual cues for each patient will allow the clinician to tailor a better treatment. The aim of this study is to evaluate the efficacy of a program based on an Individually Adjusted Therapy scale added to a treatment as usual for the treatment of addiction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

July 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

July 31, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

3.8 years

First QC Date

July 20, 2018

Last Update Submit

July 21, 2025

Conditions

Addictive BehaviorSubstance-Related Disorders

Keywords

AddictionHigh-risk relapse situationCravingIndividual cuesIndividually tailored treatment

Outcome Measures

Primary Outcomes (1)

  • Craving intensity (BILAN-7 jours)

    Craving intensity measured by the difference in craving intensity score at baseline and 3-month follow-up

    3 month

Secondary Outcomes (4)

  • Adjusted Therapy Scale (ATI)

    Week 1 to Week 11

  • Addiction Severity Index (ASI)

    Week 1 to Week 11

  • Cues of each participant (QSA)

    Week 1 to Week 11

  • Mini International Neuropsychiatric Interview (MINI)

    Week 1 to Week 11

Study Arms (2)

Traitment as usual adjusted on ATI information

EXPERIMENTAL

Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.

Procedure: Weekly assessment ajusted

Traitment as usual

ACTIVE COMPARATOR

Assessments with a multidisciplinary team (doctors, nurses, psychologists, psychiatrists, social workers) once a week during 3 months.

Procedure: Weekly assessment

Interventions

Weekly assessmentPROCEDURE

Weekly assessment during 3 months : Severity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours)

Traitment as usual
Weekly assessment ajustedPROCEDURE

Weekly assessment during 3 months : Severity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours) Individually Adjusted Therapy scale (ATI)

Traitment as usual adjusted on ATI information

Eligibility Criteria

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

You may qualify if:

  • years old or older
  • Meet DSM-5 substance use disorder diagnosis for at least one substance (alcohol, tobacco, cannabis, opiates, cocaine or any other substance) use disorder or behavioral addiction (gambling, screens, video games, food addiction, sex addiction, compulsive purchases), currently not stabilized
  • Seek treatment for this a substance use disorder or behavioral addiction
  • Ability to identify a priority substance/behavior, as main object of treatment, in case of simultaneous treatment on several addictions
  • Beneficiary of the French Social Security system
  • Give an informed consent to participate

You may not qualify if:

  • Severe physical or psychiatric or addictologic condition that prevents an outpatient treatment
  • Severe physical or psychiatric condition that prevents to complete the assessment
  • Addictive disorder that requires several treatment for several substance use disorder simultaneously
  • Difficulty to understand and to write French
  • Could not be reachable by phone
  • Participate to another study that prevents to participate to another research
  • Prisoner
  • Person under law protection
  • Person under legal guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bordeaux University Hospital

Bordeaux, 33076, France

Location

Centre Hospitalier Charles Perrens

Bordeaux, 33076, France

Location

Centre Hospitalier Esquirol

Limoges, 87 025, France

Location

Centre Hospitalier Universitaire La Réunion

Saint-Denis, 97 405, France

Location

MeSH Terms

Conditions

Behavior, AddictiveSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Mélina Fatseas

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

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

July 20, 2018

First Posted

July 31, 2018

Study Start

July 31, 2019

Primary Completion

May 2, 2023

Study Completion

August 1, 2023

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations

FR(4)