Back to resultsProcess of Regulation in Addictions: Vulnerability Emotional Factors to Craving (Procrav)
Primary Purpose
Craving, Emotional Dysfunction, Self-Regulation, Emotion
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients with completed rehab
Sponsored by
About this trial
This is an interventional health services research trial for Craving focused on measuring vulnerability
Eligibility Criteria
Inclusion Criteria:
- Patient, men or women between 18 and 60 years-old
- Patient with a diagnosis of moderate to severe dependence (DSM 5) to cocaine with or without co-addictions to alcohol or psychostimulant.
- Patient on day-hospitalisation or full hospitalisation
- Patient affiliated or beneficiary to a social security scheme.
- Patient having signed the free and informed consent.
Exclusion Criteria:
- Patient with psychiatric disorders psychosis type
- Patient with severe chronic somatic disease.
- Patient participating in another clinical study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- Pregnant, breastfeeding or parturient woman.
- Patient hospitalized without consent.
Sites / Locations
- Clinique privéeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with completed rehab
Arm Description
The aim of this research is to follow-up a cohort of patients at the end of their detoxification cure (cocaïne).
Outcomes
Primary Outcome Measures
Cocaïne craving evaluation
Using the French version of the questionnaire CCQ-Brief "Cocaïne Craving Questionnaire".
Secondary Outcome Measures
Full Information
NCT ID
NCT05076201
First Posted
September 30, 2021
Last Updated
September 30, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
Ramsay santé
1. Study Identification
Unique Protocol Identification Number
NCT05076201
Brief Title
Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving
Acronym
Procrav
Official Title
Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
November 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Ramsay santé
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to have a better understanding of the relationship between self-controle difficulties (and more specifically the inhibition deficit in impulsivity), emotional regulation disorders such as alexithymia and craving.This study will be the first in France to specify the interactions between self-regulkation processes dysfunctions and emotional dysfunctions in craving.
Detailed Description
The main objective is to measure the level of cocaine craving, 6 months after the end of their detoxification treatment (outpatient or full hospitalization), in patients with a diagnosis of moderate to severe dependence (DSM 5) to cocaine and co-addiction, or not, to alcohol and / or psychostimulants. To evaluate cocaïne craving,the questionnaire CCQ-Brief will be used.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craving, Emotional Dysfunction, Self-Regulation, Emotion, Alexithymia, Cocaine Addict
Keywords
vulnerability
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with completed rehab
Arm Type
Experimental
Arm Description
The aim of this research is to follow-up a cohort of patients at the end of their detoxification cure (cocaïne).
Intervention Type
Behavioral
Intervention Name(s)
Patients with completed rehab
Intervention Description
The main objective is to measure the level of cocaine craving, 6 months after the end of their detoxification treatment (outpatient or full hospitalization), in patients with a diagnosis of moderate to severe dependence (DSM 5) to cocaine and co-addiction, or not, to alcohol and / or psychostimulants. To evaluate cocaïne craving,the questionnaire CCQ-Brief will be used.
Primary Outcome Measure Information:
Title
Cocaïne craving evaluation
Description
Using the French version of the questionnaire CCQ-Brief "Cocaïne Craving Questionnaire".
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient, men or women between 18 and 60 years-old
Patient with a diagnosis of moderate to severe dependence (DSM 5) to cocaine with or without co-addictions to alcohol or psychostimulant.
Patient on day-hospitalisation or full hospitalisation
Patient affiliated or beneficiary to a social security scheme.
Patient having signed the free and informed consent.
Exclusion Criteria:
Patient with psychiatric disorders psychosis type
Patient with severe chronic somatic disease.
Patient participating in another clinical study
Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Pregnant, breastfeeding or parturient woman.
Patient hospitalized without consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
06 83 34 65 67
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Clinique privée
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François Oudet
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
12. IPD Sharing Statement
Learn more about this trial
Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving
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