Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving (Procrav)

September 30, 2021 updated by: Ramsay Générale de Santé
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with completed rehab
The aim of this research is to follow-up a cohort of patients at the end of their detoxification cure (cocaïne).
Behavioral: Patients with completed rehab
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cocaïne craving evaluation
Time Frame: 6 months
Using the French version of the questionnaire CCQ-Brief "Cocaïne Craving Questionnaire".
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

Ramsay santé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2019

Primary Completion (Actual)

November 20, 2020

Study Completion (Anticipated)

November 20, 2021

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A01248-49

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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