Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving

Craving Clinical Trial

— Procrav  

Official title:

Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05076201
• Other study ID #: 2019-A01248-49
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: November 20, 2021

Study information

• Verified date: September 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 06 83 34 65 67
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 20, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Affective Symptoms
• Alexithymia
• Craving
• Emotional Dysfunction

Intervention

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.

Locations

Country	Name	City	State
France	Clinique privée	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Ramsay santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaïne craving evaluation	Using the French version of the questionnaire CCQ-Brief "Cocaïne Craving Questionnaire".	6 months