Clinical trial NCT02416050: Predicting Relapse After Cocaine Inpatient Cessation
Official title: Prospective Prediction of Cocaine Relapse After Inpatient Cessation by Combining Functional Imaging and Neuropsychological Biomarkers With Craving and Impulsivity Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cocaine Dependence
Cocaine Use Disorder
Keywords: Cocaine
Dependence
Abstinence
Prediction
Model
Humans
MRI
Cognitive
Impulsivity
Craving
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cocaine dependent patient requiring inpatient cessation

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: mean difference of fractional anisotropy of the prefrontal cortex (PFC) in patients abstinent from cocaine 3 months after inpatient detoxification compared to relapsers
timeFrame: at 3 months
Secondary outcomes:
measure: Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse
timeFrame: at baseline
measure: Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse
timeFrame: at baseline
measure: Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse
timeFrame: at baseline
measure: 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
timeFrame: at 3 months
measure: Among abstinent patients who remain abstinent at three months only: Differences in scores of craving (visual scale and OCCS questionnaire) and impulsivity (UPPS)
timeFrame: at 3 months
measure: 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
timeFrame: at 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Psychiatrie, Hôpital Fernand Widal
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Florence VORSPAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: