Predicting Relapse After Cocaine Inpatient Cessation

Completed

• Conditions: Cocaine Use Disorder; Cocaine Dependence

• Registration Number: NCT02416050
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2015-02-02
• Study Start: 2015-02-03
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-14
• Primary Completion: 2022-01-03
• Study Completion: 2022-01-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse	at baseline	Differences in performance at the stroop test and in mental flexibility during an implicit set shifting task
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	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)	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	at 3 months

Trial Locations

Locations (1)

Service de Psychiatrie, Hôpital Fernand Widal; 🇫🇷 Paris, France