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Drug UseSTNdrugaddictNCT03508362

Neurobiological Substrate of Social Context on Cognitive Control in Drug Users

A study testing Functional Magnetic Resonance Imaging (fRMI) in people with Drug Use, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the present project is to reveal, using Functional Magnetic Resonance Imaging (fMRI) in drug users, a specific modulation of brain structures and circuits involved in cognitive control (and especially those of inhibitory control) and reward while subjects are performing under the influence of… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Drug Use
What is being tested?
Functional Magnetic Resonance Imaging (fRMI)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
16 Apr 2018to 15 Apr 2020
Phase
Interventional
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Drug Users Group
  • age between 18 and 65 years
  • regular use of cocaine and crack
  • willing to participate
  • able to give consent
  • not meeting any non-inclusion criteria
Show all 14Show fewer
  • right-handed
  • Healthy volunteers group
  • age between 18 and 65 years
  • non-drug user
  • willing to participate
  • able to give consent
  • not meeting any non-inclusion criteria
  • right-handed

Who cannot join

  • protected persons
  • lactating women
  • intolerance to noise
  • not a beneficiary of a social security scheme.
  • no signature on the consent form
  • significant psychiatric or neurological disorder
Show all 10Show fewer
  • known visual impairment and abnormal vision despite correction
  • Contraindication to MRI examination
  • Claustrophobia.
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

Nicolas SIMON, PU-PH contact

491744051 ext. +33

nicolas.simon@ap-hm.fr

Christelle Baunez, PhD, HDR contact

491324062 ext. +33

christelle.baunez@univ-amu.fr

France1 site, 1 recruiting
  • Assistance Publique Hôpitaux de Marseille

    Marseille, 13354

    Nicolas SIMON, PU-PH, 491744051 ext. +33, nicolas.simon@ap-hm.fr

    Christelle BAUNEZ, PhD, HDR, 491324062 ext. +33, christelle.baunez@univ-amu.fr

    Recruiting

Other trials in France

About this study

The aim of the present project is to reveal, using Functional Magnetic Resonance Imaging (fMRI) in drug users, a specific modulation of brain structures and circuits involved in cognitive control (and especially those of inhibitory control) and reward while subjects are performing under the influence of drug-associated cues and in various social contexts.

This hypothesis, based on the animal work, is that the subthalamic nucleus (STN) should play a critical role in these processes. Addictive behaviour can be seen as a loss of control resulting from reduced inhibitory control, leading to compulsive drug use. These disorders are known to be associated with a hypoactivation of specific frontal regions such as the anterior cingulate cortex or the prefrontal cortex.

Read more

For the present experiment, it is chosen to use a procedure well established for neurophysiological and behavioural assessment of inhibitory processes : the " stop-signal reaction time task ".

This task requires to inhibit a motor response (press a button) at the onset of a stop signal (a tone) that occurs while the response is already engaged. In this task associated with fMRI, it was previously shown that the STN is involved in the control of inhibition. These results confirm our data in the rat, and especially those showing that STN lesions block the ability to stop. The stop signal task will thus be appropriate to study the effect of the social context on inhibitory processes in a population of cocaine users.

In cocaine abusers, it was shown that inhibitory processes are affected. Here we aim at testing this population of subjects while they perform the stop task, but adding an implicit cognitive load induced by visual cues associated or not with cocaine intake. Since it want to assess the influence of a peer on both the performance and the associated cerebral activities, it will also control the presence of a peer observer in the procedure.

There will thus be three experimental factors, one inter-subject factor (the experimental group, cocaine users or controls) and two intra-subject factors (cocaine associated or neutral cue; presence of a peer observer). The "stop-signal" task should induce increased activity of the STN that should be modulated by the cocaine-associated cues and by the presence of a peer.

Conditions
Drug Use
Being tested
Functional Magnetic Resonance Imaging (fRMI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Magnetic Resonance Imaging (fRMI)Device

    Acquisition of a functional MRI on the sub thalamic nucleus

Study groups in NCT03508362
Study groupRoleWhat they receive
Drug userExperimentalRegular use of cocaine
Receives: Device: Functional Magnetic Resonance Imaging (fRMI)
Healthy volunteersActive comparatornon-drug user
Receives: Device: Functional Magnetic Resonance Imaging (fRMI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional MRI highlighting a specific modulation of the structures involved in the cognitive control circuit

    Compare in each group the regional brain activity through the measurement of cerebral oxygenation (blood oxygenation level dependent, BOLD). Increased activity in the subthalamic nucleus (STN) in relation to drug use.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2018
  2. Study start16 Apr 2018
  3. Primary completion15 Apr 2020 (estimated)
  4. Study completion15 Apr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03508362
Sponsor's protocol ID
2017-64
Other IDs
2017-A03395-48
Acronym
STNdrugaddict
Status last verified
Apr 2018
First submitted
16 Apr 2018
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Functional Magnetic Resonance Imaging (fRMI) in people with Drug Use, run by Assistance Publique Hopitaux De Marseille 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 14 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Apr 2018. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicolas SIMON, PU-PH (491744051 ext. +33, nicolas.simon@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional MRI highlighting a specific modulation of the structures involved in the cognitive control circuit (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Apr 2018.

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