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Sviluppo di metodi di neuroimaging per valutare la neurobiologia della dipendenza

Background:

Abusing alcohol, drugs, and other substances can cause serious health problems. These substances also can affect brain function. Researchers want to learn more about brain function by using magnetic resonance imaging (MRI). This uses a magnetic field and radio waves to take pictures of the brain.

Objective:

To develop new ways to use MRI to study the brain.

Eligibility:

Healthy people 18 years of age or older.

Design:

Participants will be screened with a medical history, physical exam, and blood and urine tests.

They will answer questions about their drug use and psychiatric history. They will be asked about family history of alcoholism or drug abuse.

Participants will answer questions to see if they can participate in MRI.

Participants will have MRI scans. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. A device called a coil may be placed over the head.

Each sub-study will include up to 3 different MRI visits. Participants can be in multiple sub-studies. But they can have only 1 MRI per week and 20 per year.

During MRI visits, participants may have urine collected. They may get another MRI questionnaire.

Participants may have a clinical MRI brain scan. This may show physical problems in the brain.

During some scans, participants may perform simple movement, memory, and thinking tasks.

Participants may be connected to a machine to monitor brain activity during the scan. Small metal electrodes will be placed on the scalp. A gel will be placed in the space between the electrodes and the scalp.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  • Objectives: To improve sensitivity as well as spectral and spatiotemporal resolutions in magnetic resonance (MR) studies assessing structural, neurochemical, hemodynamic and electrophysiological changes that occur in the human brain during the resting state as well as those that occur in response to novel sensory, motor, cognitive or emotional stimulation paradigms.
  • Study population: We intend to complete studies in 128 healthy volunteers, (64 males and 64 females, 18 years or older).
  • Design: We will conduct pilot studies, each with up to 16 subjects, to optimize MR pulse sequences and/or functional MR imaging (fMRI) task paradigms pertinent to the theme of Addiction . MR pulse sequences and/or fMRI task paradigms will be validated against

appropriated gold-standard methods/tasks. These studies are required to maximize the sensitivity of new imaging techniques and fMRI tasks used for clinical and research applications that take advantage of 3T MRI scanners at NIH. If an exploratory study leads to results of interest, and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot studies performed in the present protocol.

  • Outcome parameters: Although multiple measures will be collected, the primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals.
  • MRI: we will analyze measures such as the amplitude and the reliability of the test-retest measures of fMRI signals; functional connectivity metrics; tractography between seed and target regions of interest (diffusion tensor imaging, DTI); brain morphometry (using

automatic segmentation and voxel-brain morphometry, VBM); and brain metabolite levels in regions of interest (using MR spectroscopy, MRS).

  • EEG (electroencephalography): we will quantify measures such as event or task-related potentials, and coherence between sensors or sources located close to the brain areas of interest.
  • Behavioral measures: during fMRI we will quantify measures such as reaction times and accuracy (using MRI compatible response pads) as well as eye movement (using MRI compatible eye trackers) and self-reports of the study experience (i.e., degree of interest

and motivation and alertness).

-Physiological measures: During fMRI, we will record physiological parameters such as blood pressure, skin conductance, respiratory frequency, or heart rate, to interpret outcome measures.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

57

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Maryland
      • Bethesda, Maryland, Stati Uniti, 20892
        • National Institutes of Health Clinical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

  • INCLUSION CRITERIA:

    1. Eighteen years or older.
    2. Ability to provide written informed consent as determined by physical examination and verbal communication. Capacity to consent will be determined by those obtaining the informed consent.
    3. Willingness to abstain from drug use on scheduled testing days.

EXCLUSION CRITERIA

  1. Positive urine pregnancy test in females.

  2. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces as determined by the self-report checklist.

  3. Claustrophobia.

  4. Body weight >550 lbs, which is the weight limit of the MR scanner.

  5. Current DSM-5 diagnosis of a psychiatric disorder (other than nicotine/caffeine use disorders) as determined by history and clinical exam including substance use disorder, alcoholism and alcohol dependence. Past history of a mental disorder as defined by DSM-IV or DSM-5 will be excluded only if it was severe enough as to require hospitalization (any length), or chronic medication management (more than 4 weeks), or that could impact brain function at the time of the study. Subjects receiving psychotherapy may be included in the study.

  6. Those with a binge drinking history every month continuously for the last 10 years will also be excluded. Binge drinkers are those who being female consume 4 or more drinks and males consume 5 or more drinks in one occasion at least once a month.

  7. Serious neurological disorder such as MS, Parkinson s Disease, ALS, sensory loss or peripheral neuropathy.

  8. Currently taking any psychoactive drugs such as Celexa (TM), Prozac (TM), Wellbutrin (TM), Zoloft (TM), and/or stimulants other than caffeine such as Adderall (TM), Dexedrine (TM) and Ritalin (TM). Subjects taking PRN medications (e.g., sleep medications) may be included in the study.

  9. Clinically significant laboratory or examination results.

  10. Study investigators and staff, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).

  11. *Non-English speakers (must also be able to read and comprehend English).

    • The intent of the research has no prospect of direct benefit to the subject. Therefore, we are excluding non-English speakers in this research study since our fMRI paradigms (particularly the Delay Discounting task) require that the subject be able to speak, read and comprehend English.

Subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs/alcohol on initial screening. However, if they test positive on scheduled study procedure days involving MRI, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days that were the result of positive urine drug or BAL screens. If the drug/BAL tests is/are positive on the third rescheduled visit, the participant will be withdrawn from the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Attentional Bias Task

Subjects will briefly see two images side by side on a screen. Immediately after, a dot appears on the left or on the right. The subjects task is to press the left or right button, following the position of the image (left or right). Images can contain food-related items. We will also show short 1-minute food-related movies. Subjects will be asked to fast for three hours before this task begins.

1H MR spectroscopy to assess brain metabolites.

Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.

Sperimentale: Cue Reactivity Task

In this task subjects will view pictures of various items on the screen in front of them. Subjects will rate the items by how much they would like to have them. Subjects will choose how much they want the item by pressing a button.

1H MR spectroscopy to assess brain metabolites.

Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.

Sperimentale: Delay Discounting Task

Subjects will be asked to imagine whether they would receive money now or money later (in the future). The future money option may be several days from now or as far out as 6 weeks from now. For example, a s ubject may see a $100 option in 6 weeks or a $10 option now. Subjects will not receive actual money for participation in this task

1H MR spectroscopy to assess brain metabolites.

Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.

Sperimentale: Motivational Reward Task

Subjects will make a choice among some items presented on the screen in front of them. One of the items will be the winner item. The other items will be loser items. Each time a subject is presented with various items, they will choose the item they think is the winner item. Subjects will start with bonus points at the beginning of the task, so they can add more points to this amount as they continue to choose winner items.

1H MR spectroscopy to assess brain metabolites.

Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.

Electroencephalography or electrooculography (EEG/ EOG) sessions to record electrical activity of the brain or measure corneo-retinal standing potentials.

Sperimentale: NSPRD Task

During the MRI scan, subjects will get small electric shocks through electrodes placed on one of their toes. The shocks feel like an elastic band snapping against the skin. Right after a shock, subjects will see a dot on the computer screen. Subejcts will press a button to rate the intensity of the shock.

1H MR spectroscopy to assess brain metabolites.

Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

To be used in conjunction with pupillometry in the context of fMRI to study blood-oxygenation-level-dependent responses to selective neurostimulation of pain fibers.

Sperimentale: Reasoning Task

Subjects will identify changes in various shapes when they are displayed on the screen in front of them. Some changes of the shapes may be that they were rotated, enlarged, or multiplied. Subjects will choose the changes in the shapes by pressing a button.

1H MR spectroscopy to assess brain metabolites.

Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.

Sperimentale: Respiratory Challenge (RC) Task

Participants will be visually instructed to take a brief deep breath (inhale) and release the breath (exhale). They will inhale and exhale one more time with visual cues at specific times (60 seconds, 120 seconds, 180 seconds, 240 seconds, etc. with successive 60 seconds intervals). A black cross will remain centered on a grey slide during the normal respiration periods. To signal the RC periods, the slide will change color to yellow READY slide, then to green BREATHE IN slide, then to blue BREATHE OUT slide. The sequence will repeat one more time to Breath In and Breath Out and then finally go back to the yellow Breathe Normally slide. The instruction words will be written on the slides. Each slide will be shown for 3 seconds. The task will take a total of 15 minutes (total of 900 seconds with 14 RC periods).

1H MR spectroscopy to assess brain metabolites.

Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.

High spatial MRI and diffusion tensor imaging (DTI) to assess brain morphology and structural connectivity.

Sperimentale: Self-control Task

During the MRI scan, subjects will do a task that requires close concentration. Subjects will be asked to respond quickly to images on the computer screen, during which they will hear distracting noises. The subject will be able to remove the distraction in order to complete the task. During some sub-study sessions, subjects will start with no money ($0) and may be able to earn up to $40 if they do not remove the distraction. At other sub-study sessions, subjects will start with $40 and may lose between 25 to $1 each time they remove the distraction. Subjects cannot lose more than $40 in these sessions. Compensation for this sub-study is up to $40 per session, depending on their performance.

1H MR spectroscopy to assess brain metabolites.

Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.

Sperimentale: Spinner Task and MID Task (monetary incentive delay task)

The Spinner task requires the subject to participate in a game of chance while lying in the MRI scanner. Subjects will be asked to respond by pressing a button. The MID task is a reaction time task. The MID Task tests how quickly a subject can press a button to hit a target on the screen in front of them. If the subject presses the button as soon as the target appears, the subject will score points. Subjects should try to score as many points as you can.

1H MR spectroscopy to assess brain metabolites.

Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals.
Lasso di tempo: end of study

MRI: we will analyze measures such as the amplitude and the reliability of the test-retest measures of fMRI signals; functional connectivity metrics; tractography between seed and target regions of interest (diffusion tensor imaging, DTI); morphometry of brain regions (using automatic segmentation and voxel-brain morphometry, VBM); and brain metabolite levels in regions of interest (using MR spectroscopy, MRS).

end of study
The primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals.
Lasso di tempo: end of study

EEG (electroencephalography): we will quantify measures such as event or task-related potentials, and coherence between sensors or sources located close to the brain areas of interest. We are also quantifying blink rates from the electrooculogram (EOG).

end of study
The primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals.
Lasso di tempo: end of study

Behavioral measures during fMRI tasks: we will quantify measures such as reaction times and accuracy (using MRI compatible response pads) as well as eye movement (using MRI compatible eye trackers) and self-reports of the study experience (i.e. degree of interest and motivation and alertness).

end of study

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Collection of autonomic data
Lasso di tempo: end of study

Autonomic data may be collected or observations made during the course of the experiment that will give further information about the state of the body and emotions during experiments (blood pressure, skin conductance, respiratory rate). Self-report data may be collected during the course of the experiment to assess the level of interest, boredom, alertness of the participants.

end of study

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Dardo G Tomasi, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 giugno 2016

Completamento primario (Effettivo)

15 novembre 2018

Completamento dello studio (Effettivo)

15 novembre 2018

Date di iscrizione allo studio

Primo inviato

28 agosto 2015

Primo inviato che soddisfa i criteri di controllo qualità

28 agosto 2015

Primo Inserito (Stimato)

31 agosto 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

21 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 150186
  • 15-AA-0186

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

The data will not be analyzed individually.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .