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Completed

NCT Number: NCT02416050

Predicting Relapse After Cocaine Inpatient Cessation

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.

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Key information

Conditions

Cocaine Dependence Behavior Chemically-Induced Disorders Cocaine Use Disorder Cocaine-Related Disorders Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Psychiatrie, Hôpital Fernand Widal

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain MRI imagery

Procedure

Brain MRI performed during the first week of inpatient cocaine cessation

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: QUIT-COC

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2015
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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