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Control Systems Approach to Predicting Individualized Dynamics of Nicotine Cravings

29 de junio de 2017 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

23

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • Stony Brook, New York, Estados Unidos, 11794
        • Bioengineering Building , Stony Brook University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Nicotine Cravings
Otros nombres:
  • Nicotrol NS

¿Qué mide el estudio?

Medidas de resultado primarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Lilianne Mujica-Parodi, PhD, Stony Brook University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2015

Finalización primaria (Actual)

1 de junio de 2017

Finalización del estudio (Anticipado)

1 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

24 de noviembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

28 de diciembre de 2015

Publicado por primera vez (Estimar)

31 de diciembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

29 de junio de 2017

Última verificación

1 de junio de 2017

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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