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Predicting Relapse After Cocaine Inpatient Cessation (QUIT-COC)

This study is currently recruiting participants.
Verified September 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT02416050
First Posted: April 14, 2015
Last Update Posted: September 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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 Intervention
Cocaine Dependence Cocaine Use Disorder Procedure: Brain MRI imagery

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 Measures:
  • 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)

  • 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)

  • 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

  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 100
Study Start Date: February 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Brain MRI imagery
    Brain MRI performed during the first week of inpatient cocaine cessation
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cocaine dependent patient requiring inpatient cessation
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416050


Contacts
Contact: Florence VORSPAN, MD, PhD 33 1 40 05 44 17 florence.vorspan@lrb.aphp.fr

Locations
France
Service de Psychiatrie, Hôpital Fernand Widal Recruiting
Paris, France, 75010
Contact: Florence VORSPAN, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Florence VORSPAN, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02416050     History of Changes
Other Study ID Numbers: P120125
2014-A01169-38 ( Other Identifier: IDRCB )
First Submitted: February 2, 2015
First Posted: April 14, 2015
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cocaine
Dependence
Abstinence
Prediction
Model
Humans
MRI
Cognitive
Impulsivity
Craving

Additional relevant MeSH terms:
Cocaine-Related Disorders
Cocaine
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents