Predicting Relapse After Cocaine Inpatient Cessation

• Register: ClinicalTrials.gov
• Last refreshed on: 20 March 2023
• Main ID: NCT02416050
• Date of registration: 02/02/2015
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Predicting Relapse After Cocaine Inpatient Cessation QUIT-COC
• Scientific title: Prospective Prediction of Cocaine Relapse After Inpatient Cessation by Combining Functional Imaging and Neuropsychological Biomarkers With Craving and Impulsivity Measures
• Date of first enrolment: February 3, 2015
• Target sample size: 87
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02416050
• Study type: Observational

Countries of recruitment

France

Contacts

• Name: Florence VORSPAN, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cocaine Use Disorder

Cocaine Dependence

Intervention(s)

Procedure: Brain MRI imagery

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse [Time Frame: 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]

Secondary ID(s)

2014-A01169-38

P120125

Source(s) of Monetary Support

Please refer to primary and secondary sponsors