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- Ensayo clínico NCT00901459
A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers (rTMS)
17 de diciembre de 2012 actualizado por: Duke University
The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) to block craving for cigarettes in smokers.
rTMS is an investigational procedure, where a device called a "stimulator" provides electricity to a device that creates a magnetic field.
This device is placed against the scalp in the front of the head so that the magnetic field is focused on an area of the brain that is thought to be involved in craving for cigarettes.
rTMS is an investigational procedure so therefore being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
Changes in magnetic fields during rTMS administration change electrical currents which may affect brain activity and function.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
The goal of this study is to evaluate the effects of rTMS on cue-induced craving in dependent smokers. We hypothesize that low frequency rTMS over the SFG will block cue-induced craving. In order to test this hypothesis, subjects will undergo three conditions:
- active condition: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues
- location control condition: low frequency rTMS was administered over motor cortex (MC) during the presentation of smoking and control cues
- frequency control condition: high frequency rTMS was administered over the SFG during the presentation of smoking and control cues
Tipo de estudio
Intervencionista
Inscripción (Actual)
21
Fase
- Fase 2
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
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Duke Center for Nicotine & Smoking Cessation Research
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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
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 18 to 50 years of age;
- dependent smoker of > 10 cigarettes per day of cigarettes yielding >0.5mg nicotine (by Federal Trade Commission rated yields);
- have smoked cigarettes for at least three cumulative years;
- an afternoon carbon monoxide reading of at least 10ppm;
- be in general good health based on physical examination, EKG, serum chemistries, CBC, and urinalysis and
- show evidence of greater craving following exposure to in vivo smoking versus control cues
Exclusion Criteria:
- Individuals with a clinically defined neurological disorder or insult including, but not limited to, any condition likely to be associated with increased intracranial pressure;
- space occupying brain lesion;
- any history of seizure EXCEPT those therapeutically induced by ECT (Electro Convulsive Therapy);
- history of cerebrovascular accident;
- transient ischemic attack within two years;
- cerebral aneurysm;
- dementia;
- Parkinson's disease;
- Huntington's chorea;
- multiple sclerosis;
- current lung disease or lung disorder;
- hypertension (systolic >140 mmHg, diastolic > 90 mmHg);
- hypotension (< 90 mmHg, diastolic < 60 mmHg);
- coronary artery disease;
- cardiac rhythm disorder;
- impaired hepatic or renal function (based on documented diagnosis or abnormal chemistries) except gallstones or kidney stones;
- other major medical or psychiatric condition;
- use of any concurrent hypertensive, psychiatric, or psychoactive medication;
- any concurrent medication that lowers seizure threshold;
- smokeless tobacco, pipe, or cigar use in the past 30 days;
- nicotine replacement therapy, or other smoking cessation therapy within the past 30 days;
- increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for > 5 minutes;
- ECT treatment within 3 months prior to screening visit;
- failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher);
- a true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire;
- history of treatment with rTMS therapy for any disorder;
- use of any investigational drug within 30 days of the screening visit;
- history of treatment with Vagus Nerve Stimulation;
- use of any medication(s) with active CNS properties within 1 week of the screening visit;
- cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease; intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- known or suspected pregnancy;
- positive urine drug screen or reported drug abuse in the past 30 days;
- clinically significant laboratory abnormality, in the opinion of the investigator or study physician;
- women who are breast-feeding; women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse;
- current chronic pain or other pain condition that interferes with daily activities or requires use of prescription medication;
- claustrophobia or abnormal fear of cramped or confined space;
- Individuals where a motor threshold response is not elicited with stimulation at or below 80% of maximum output;
- active ulcer within the past 30 days;
- frequent migraines (great than four in the past 30 days);
- Females who score greater than or equal to 13 and males who score greater than or equal to 15 on the AUDIT (Alcohol Use Disorders Identification Test)will be excluded from the study.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: rTMS 90% MT - Low frequency rTMS
Intervention type: device.
Intervention description: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues using 90% MT (Motor Threshold) 1 Hz rTMS Dose on Superior Frontal Gyrus
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Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.
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Comparador activo: Location Control
rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
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Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the motor cortex (MC) during the presentation of smoking and control cues.
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Comparador activo: Frequency Control
rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
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High frequency rTMS (90% Motor Threshold at 10 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.
Periodo de tiempo: Following exposure to in vivo cues
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Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING ("urges to smoke," "miss a cigarette," and "crave cigarettes"), MOOD ("calm," "tense," and "irritable"), AROUSAL ("wide awake," "able to concentrate"), and HUNGER ("feel hungry").
The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely.
The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome.
A negative value represents a decrease in reported cigarette craving.
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Following exposure to in vivo cues
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Craving for Cigarettes After Controlled Smoke Presentations.
Periodo de tiempo: After smoking a cigarette through the controlled puff volume apparatus during rTMS
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Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire ("Did it immediately reduce your craving for cigarettes?") after smoking presentations through the controlled puff volume apparatus.
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After smoking a cigarette through the controlled puff volume apparatus during rTMS
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Andrew D Krystal, M.D., M.S., Duke 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 mayo de 2009
Finalización primaria (Actual)
1 de agosto de 2010
Finalización del estudio (Actual)
1 de agosto de 2010
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2009
Primero enviado que cumplió con los criterios de control de calidad
12 de mayo de 2009
Publicado por primera vez (Estimar)
13 de mayo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
25 de enero de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
17 de diciembre de 2012
Última verificación
1 de diciembre de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00002339
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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