Completado

P1S1Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

very low nicotine content cigarettes

+ very low nicotine content cigarettes

+ very low nicotine content cigarettes

Otro
Quiénes están siendo reclutados

Trastornos Mentales

+ Trastorno por uso de tabaco

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Ciencia Básica

Intervencional
Inicio del estudio: junio de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalWake Forest University Health Sciences
Última actualización: 15 de agosto de 2018
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de junio de 2013

Fecha en la que se inscribió al primer participante.

Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.

NCT01681875
Patrocinador PrincipalWake Forest University Health Sciences
Última actualización: 15 de agosto de 2018
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 839 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Ciencia Básica

Los estudios de ciencia básica ayudan a los investigadores a comprender cómo funciona el cuerpo o cómo se desarrolla una enfermedad. No prueban tratamientos, pero sientan las bases para terapias futuras.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastornos MentalesTrastorno por uso de tabaco

Criterios

Inclusion Criteria: Age 18+ Smoke an average of at least five cigarettes per day for at least 1 year Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2) Exclusion Criteria: Intention to quit smoking in the next 30 days Currently seeking treatment for smoking cessation Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable) A quit attempt in the past 30 days resulting in greater than 3 days of abstinence Using other tobacco products more than 9 days in the past 30 days Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site) Significant unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site) Schizophrenia and schizoaffective disorder Psychiatric medication changes in the past 3 months Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP Marijuana will be tested for but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once. Blood alcohol level > 0.01 a. Participants failing the blood alcohol screen will be allowed to re-screen once. Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 in a 2 hour period(female/male)) Pregnant or breastfeeding Smoking 'roll your own cigarettes' exclusively Currently taking anticonvulsant medication CO reading >80 ppm Systolic BP greater than or equal to 160 a. Participants failing for blood pressure will be allowed to re-screen once. Diastolic BP greater than or equal to 100 a. Participants failing for blood pressure will be allowed to re-screen once. Systolic BP below 90 a. Participants failing for blood pressure will be allowed to re-screen once. Diastolic BP below 50 a. Participants failing for blood pressure will be allowed to re-screen once. Heart rate greater than or equal to 115bpm a. Participants failing for heart rate will be allowed to re-screen once. Heart rate lower than 45bpm a. Participants failing for heart rate will be allowed to re-screen once. Indicating any suicidal ideation in the past month or suicide attempts in the past 10 years Inability to independently read and comprehend the consent form and other written study materials and measures Having participated in a research study during the past three months in which the participant: Smoked a cigarette that was not his/her usual brand cigarette for more than one day Used any tobacco products beyond normal use for more than one day Used any nicotine replacement products or smoking cessation medications for more than one day

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

7 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
very low nicotine content cigarettes SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)

Grupo II

Experimental
very low nicotine content cigarettes SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar

Grupo III

Experimental
very low nicotine content cigarettes SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar

Grupo IV

Experimental
very low nicotine content cigarettes SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar

Grupo 5

Experimental
very low nicotine content cigarettes SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar

Grupo 6

Experimental
very low nicotine content cigarettes SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar

Grupo 7

very low nicotine content cigarettes Usual brand cigarettes (control condition)

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 9 ubicaciones

University of California San Francisco

San Francisco, United StatesAbrir University of California San Francisco en Google Maps

Moffitt Cancer Center

Tampa, United States

Johns Hopkins University

Baltimore, United States

University of Minnesota Medical School Duluth

Duluth, United States
Completado9 Centros de Estudio