Predicting Relapse After Cocaine Inpatient Cessation

Cocaine Dependence Clinical Trial

— QUIT-COC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416050
• Other study ID #: P120125
• Secondary ID: 2014-A01169-38
• Status: Completed
• Start date: February 3, 2015
• Est. completion date: January 3, 2022

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 3, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine Use Disorder
• Cocaine-Related Disorders

Intervention

Procedure:
• Brain MRI imagery
Brain MRI performed during the first week of inpatient cocaine cessation

Locations

Country	Name	City	State
France	Service de Psychiatrie, Hôpital Fernand Widal	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse	Differences in grey and white matter volumes : voxel-based morphometry (VBM) and in resting-state whole-brain activity default mode network (DMN)	at baseline
Secondary	Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse	Differences in scores of craving (visual scale and Obsessive compusilve craving scale (OCCS) questionnaire) and impulsivity (UPPS)	at baseline
Secondary	Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse	Differences in performance at the stroop test and in mental flexibility during an implicit set shifting task	at baseline
Secondary	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
Secondary	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
Secondary	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