Predicting Relapse After Cocaine Inpatient Cessation (QUIT-COC)

March 10, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Prospective Prediction of Cocaine Relapse After Inpatient Cessation by Combining Functional Imaging and Neuropsychological Biomarkers With Craving and Impulsivity Measures

Can brain MRI at entry of cocaine inpatient cessation attempt predict relapse during a three month follow-up ? Hypothesis : White matter losses in the prefrontal cortex are associated with relapse to cocaine use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multivariate model using MRI parameters, craving score, impulsivity score, and neuropsychological testing results will be tested to predict relapse or continuous abstinence three month after cocaine inpatient cessation attempt.

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

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

Study Locations

  • France
      • Paris, France, 75010
        • Service de Psychiatrie, Hôpital Fernand Widal

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cocaine dependent patient requiring inpatient cessation

Description

Inclusion Criteria:

  • cocaine dependent patient requiring inpatient cessation
  • 18 years old and older
  • giving his/her consent to come back for visits up to three months
  • having a social insurance

Exclusion Criteria:

  • minor
  • under guardianship
  • restraint hospitalization
  • contraindication to brain MRI
  • pregnant women

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean difference of fractional anisotropy of the prefrontal cortex (PFC) in patients abstinent from cocaine 3 months after inpatient detoxification compared to relapsers
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse
Time Frame: at baseline
Differences in grey and white matter volumes : voxel-based morphometry (VBM) and in resting-state whole-brain activity default mode network (DMN)
at baseline
Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse
Time Frame: at baseline
Differences in scores of craving (visual scale and Obsessive compusilve craving scale (OCCS) questionnaire) and impulsivity (UPPS)
at baseline
Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse
Time Frame: at baseline
Differences in performance at the stroop test and in mental flexibility during an implicit set shifting task
at baseline
Among abstinent patients who remain abstinent at three months only :Differences between baseline and 3 months measures of Diffusion Tensor Imagery (DTI), VBM and DMN
Time Frame: at 3 months
at 3 months
Among abstinent patients who remain abstinent at three months only: Differences in scores of craving (visual scale and OCCS questionnaire) and impulsivity (UPPS)
Time Frame: at 3 months
at 3 months
Among abstinent patients who remain abstinent at three months only: Differences in performance at the stroop test and in mental flexibility during an implicit set shifting task compared to baseline results
Time Frame: at 3 months
at 3 months

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Florence VORSPAN, MD, PhD, Assistance Publique - Hôpitaux de Paris

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

February 3, 2015

Primary Completion (Actual)

January 3, 2022

Study Completion (Actual)

January 3, 2022

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P120125
  • 2014-A01169-38 (Other Identifier: IDRCB)

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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