Cocaine DependenceQUIT-COCNCT02416050
Predicting Relapse After Cocaine Inpatient Cessation
An observational study of Cocaine Dependence and Cocaine Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Dependence, Cocaine Use Disorder
- What is being tested?
- Brain MRI imagery
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2015to 3 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cocaine dependent patient requiring inpatient cessation
Who may be able to join
- 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
Who cannot join
- minor
- under guardianship
- restraint hospitalization
- contraindication to brain MRI
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Prediction of Cocaine Relapse After Inpatient Cessation by Combining Functional Imaging and Neuropsychological Biomarkers With Craving and Impulsivity Measures
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.
Read the 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.
- Conditions
- Cocaine Dependence, Cocaine Use Disorder
- Being tested
- Brain MRI imagery
- Keywords
- Cocaine, Dependence, Abstinence, Prediction, Model, Humans, MRI, Cognitive, Impulsivity, Craving
- Medical subject headings
- Cocaine-Related Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRI imageryProcedure or surgery
Brain MRI performed during the first week of inpatient cocaine cessation
What is being measured
The primary outcome is the main question the study is designed to answer.
mean difference of fractional anisotropy of the prefrontal cortex (PFC) in patients abstinent from cocaine 3 months after inpatient detoxification compared to relapsers
Measured: at 3 months
Secondary outcomes (6)
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)
Measured: at baseline
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)
Measured: at baseline
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
Measured: 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
Measured: 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)
Measured: 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
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start3 Feb 2015
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence VORSPAN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416050
- Sponsor's protocol ID
- P120125
- Other IDs
- 2014-A01169-38
- Acronym
- QUIT-COC
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2015
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poireau M, Clergue-Duval V, Maillard A, Icick R, Azuar J, Smith P, Faurent M, Volle E, Delmaire C, Cabe J, Bloch V, Vorspan F. Predictors of abstinence maintenance after cocaine inpatient detoxification: A prospective study. Am J Addict. 2024 Sep;33(5):576-582. doi: 10.1111/ajad.13571. Epub 2024 May 18.
PubMed 38761123
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Prediction of Cocaine Relapse After Inpatient Cessation by Combining Functional Imaging and Neuropsychological Biomarkers With Craving and Impulsivity Measures
- ClinicalTrials.gov ID
- NCT02416050
- Acronym / sponsor ID
- QUIT-COC / P120125
- Conditions
- Cocaine Dependence, Cocaine Use Disorder
- Keywords
- Cocaine, Dependence, Abstinence, Prediction, Model, Humans, MRI, Cognitive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Feb 2015
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cocaine dependent patient requiring inpatient cessation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- minor
- under guardianship
- restraint hospitalization
- contraindication to brain MRI
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRI imageryBrain MRI performed during the first week of inpatient cocaine cessation | Procedure or surgery | – |
Primary outcome
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
6 secondary outcomes
Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse
Time frame: at baseline
Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse
Time frame: at baseline
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Derived from this study: PubMed 38761123Poireau M, Clergue-Duval V, Maillard A, Icick R, Azuar J, Smith P, Faurent M, Volle E, Delmaire C, Cabe J, Bloch V, Vorspan F. Predictors of abstinence maintenance after cocaine inpatient detoxification: A prospective study. Am J Addict. 2024 Sep;33(5):576-582. doi: 10.1111/ajad.13571. Epub 2024 May 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence VORSPAN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Dependence and Cocaine Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02416050, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.