NCT05076201

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.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 20, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2021

Completed
Last Updated

October 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 30, 2021

Last Update Submit

September 30, 2021

Conditions

Keywords

vulnerability

Outcome Measures

Primary Outcomes (1)

  • Cocaïne craving evaluation

    Using the French version of the questionnaire CCQ-Brief "Cocaïne Craving Questionnaire".

    6 months

Study Arms (1)

Patients with completed rehab

EXPERIMENTAL

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

Interventions

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.

Patients with completed rehab

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique privée

Marseille, 13009, France

RECRUITING

MeSH Terms

Conditions

Emotional RegulationAffective Symptoms

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorBehavioral Symptoms

Central Study Contacts

Jean-François Oudet

CONTACT

Marie-Hélène Barba

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 13, 2021

Study Start

November 20, 2019

Primary Completion

November 20, 2020

Study Completion

November 20, 2021

Last Updated

October 13, 2021

Record last verified: 2021-09

Locations