Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Control Systems Approach to Predicting Individualized Dynamics of Nicotine Cravings

29. juni 2017 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

23

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • New York
      • Stony Brook, New York, Forente stater, 11794
        • Bioengineering Building , Stony Brook University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Nicotine Cravings
Andre navn:
  • Nicotrol NS

Hva måler studien?

Primære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2015

Primær fullføring (Faktiske)

1. juni 2017

Studiet fullført (Forventet)

1. desember 2017

Datoer for studieregistrering

Først innsendt

24. november 2015

Først innsendt som oppfylte QC-kriteriene

28. desember 2015

Først lagt ut (Anslag)

31. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere