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Control Systems Approach to Predicting Individualized Dynamics of Nicotine Cravings

29 juni 2017 bijgewerkt door: Lilianne Strey, Stony Brook University

Using Control Systems to Predict Individualized Dynamics of Nicotine Cravings

Nicotine is the most common drug of abuse in the United States, and has addiction strength comparable to cocaine, heroin, and alcohol. It is the primary addictive component of tobacco, and its use markedly increases risk for cancer, heart disease, asthma, miscarriage, and infant mortality. Addiction is thought to be caused primarily by the intersection of two components: 1) the impact of drug pharmacokinetics on the dynamics of dopamine response, and 2) dysregulation of the brain's reward circuit. While the term 'dysregulated' tends to be used qualitatively within the neuroscience literature, regulation has a precise and testable meaning in control systems engineering, which has yet to be addressed in a quantitative manner by current neuroimaging methods or models of addiction. Current approaches to neuroimaging have primarily focused on identifying nodes and causal connections within the meso-circuit of interest, but have yet to take the next step in treating these nodes and connection as a self-interacting dynamical system evolving over time. Such an approach is critical for improving our understanding, and therefore prediction, of trajectories for addiction as well as recovery.

Studie Overzicht

Gedetailleerde beschrijving

Nicotine is the most common drug of abuse in the United States, and has addiction strength comparable to cocaine, heroin, and alcohol. It is the primary addictive component of tobacco, and its use markedly increases risk for cancer, heart disease, asthma, miscarriage, and infant mortality. Addiction is thought to be caused primarily by the intersection of two components: 1) the impact of drug pharmacokinetics on the dynamics of dopamine response, and 2) dysregulation of the brain's reward circuit. While the term 'dysregulated' tends to be used qualitatively within the neuroscience literature, regulation has a precise and testable meaning in control systems engineering, which has yet to be addressed in a quantitative manner by current neuroimaging methods or models of addiction. Current approaches to neuroimaging have primarily focused on identifying nodes and causal connections within the meso-circuit of interest, but have yet to take the next step in treating these nodes and connection as a self-interacting dynamical system evolving over time. Such an approach is critical for improving the understanding, and therefore prediction, of trajectories for addiction as well as recovery. These trajectories are likely to be nonlinear (e.g., involving thresholds, saturation, and self-reinforcement), as well as highly specific to each individual. This study is designed to provide the first step towards addressing this gap: integrating ultra-high-field (7T) and ultra-fast (<1s) fMRI with computational modeling, to provide a bridge between the dynamics of meso-circuit regulation and the dynamics of human addictive behavior. The investigators propose to test the hypothesis that control systems regulation, measured by dynamic analyses of fMRI data, can predict-on an individual basis-exactly when an addicted smoker will want to take his next puff. This will be achieved by first validating a MR-compatible nicotine delivery system, by comparing its neurobiological and autonomic effects against those of a cigarette and e-cigarette. Once this is achieved, the investigators will then acquire fMRI data from addicted smokers while they 'smoke.' Using individual subjects' neuroimaging data, the investigators will derive coupled differential equations for a control system that predicts craving and behavioral response for that individual. Using independent data sets to estimate the parameters and to test them, the investigators will assess the model's accuracy in predicting each individual subject's cravings, as measured behaviorally by the frequency at which each smoker self-administers nicotine. If successful, this approach could then be exploited to develop individualized prevention and treatment of addiction by identifying individual-specific amplitude, duration, and frequency of dosing in nicotine replacement therapy that is least likely to trigger cravings. More generally, the methods proposed have the potential to rigorously examine system-wide dysregulation in addiction for the first time, opening the door to exploration of other dysregulatory brain-based diseases in humans.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

23

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • New York
      • Stony Brook, New York, Verenigde Staten, 11794
        • Bioengineering Building , Stony Brook University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

21-65years of age

Moderate to severe addiction to smoking/nicotine

Willingness to withdraw from nicotine for 12 hours prior to testing

Eyesight correctable to 20/20 with contact lenses.

Exclusion Criteria:

Electrical implants such as cardiac pacemakers or perfusion pumps

Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, facial tattoos, or steel implants

Claustrophobia

Pregnancy or breastfeeding (for females, pregnancy status will be confirmed with urine test)

Chronic nasal congestion, sinusitis, or common cold Use of nicotine cessation therapy (patch, gum, inhaler, nasal spray)

History of asthma, cardiovascular or peripheral vascular disease (anginas, arrhythmias, myocardial infarction, Raynaud's disease, insulin dependent diabetes)

History of neurological disease (brain tumor, stroke, traumatic brain injury, epilepsy)

Current use of psychotropic medication

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Nicotine Cravings
Andere namen:
  • Nicotrol NS

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Autonomic nervous system activity will be measured by analysis of heart rate variability and electric dermal activity alongside a 0-10 craving scale.
Tijdsspanne: through study completion, an average of 1 year
through study completion, an average of 1 year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Lilianne Mujica-Parodi, PhD, Stony Brook University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2015

Primaire voltooiing (Werkelijk)

1 juni 2017

Studie voltooiing (Verwacht)

1 december 2017

Studieregistratiedata

Eerst ingediend

24 november 2015

Eerst ingediend dat voldeed aan de QC-criteria

28 december 2015

Eerst geplaatst (Schatting)

31 december 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juli 2017

Laatste update ingediend die voldeed aan QC-criteria

29 juni 2017

Laatst geverifieerd

1 juni 2017

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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