- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02416050
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
-
-
-
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.
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
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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