QUIT-COC: Predicting Relapse After Cocaine Inpatient Cessation

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Terminated
CT.gov ID
NCT02416050
Collaborator
(none)
87
1
83
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Brain MRI imagery

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 Design

Study Type:
Observational
Actual Enrollment :
87 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Prospective Prediction of Cocaine Relapse After Inpatient Cessation by Combining Functional Imaging and Neuropsychological Biomarkers With Craving and Impulsivity Measures
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Jan 1, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse [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 [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 [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 [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) [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 [at 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Psychiatrie, Hôpital Fernand Widal Paris France 75010

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Florence VORSPAN, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02416050
Other Study ID Numbers:
  • P120125
  • 2014-A01169-38
First Posted:
Apr 14, 2015
Last Update Posted:
Feb 22, 2022
Last Verified:
Feb 1, 2022
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 22, 2022