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Does Smoking Cessation Increase Anhedonia? A Test of Pre-clinical Findings

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Qué se está evaluando

Smokers cease smoking

Conductual
Quiénes están siendo reclutados

Enfermedades del sistema nervioso+1

+ Manifestaciones Neurológicas

+ Signos y Síntomas

A partir de 18 años
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Cómo está diseñado el estudio

Estudio de Ciencia Básica

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

Resumen

Patrocinador PrincipalUniversity of Vermont
Última actualización: 14 de marzo de 2016
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de abril de 2013

Fecha en la que se inscribió al primer participante.

Study design We will recruit until we have 70 current smokers who want to quit at two sites (Univ of Vermont and Dartmouth Medical School). We will also recruit a comparison group of 70 long-time former smokers to assist in interpretation of the results. In the first week, smokers will smoke their usual number of cigs/day. They will then quit and are to remain abstinent for 4 weeks. We will use a schedule of escalating monetary contingencies based on breath and saliva and/or urine samples to encourage abstinence. We will obtain dependent measures twice/week. The primary measures of reward responsivity will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task and the score on our Rewarding Events scale. Other outcomes will be delay discounting results and self-reports of anhedonia and apathy. The study will run for 1 week pre-cessation (2 visits) and then for 4 weeks post-cessation. Measures and biochemical verifications will occur twice/wk. Former smokers will attend once a wee for four weeks. For the first week of abstinence, the cutoff for nonsmoking will be CO <8 ppm. For the remaining weeks, abstinence will be verified with a score of 0 (<10 ng/ml of cotinine) on a test strip in a saliva or urine sample plus a CO <8 ppm. At the initial session, completion of baseline surveys will describe the sample and also measure plausible moderators such as depression. We believe the most direct test of reward sensitivity is an evaluation of the influence of abstinence on operant responding for a reward. Thus, we have chosen performance on the Effort Expenditure for Rewards Task (EEfRT), which examines responding as a function of response cost, reward magnitude and probability of reward, as one of our primary outcomes. For a self-report measure we will use our Rewarding Events (RE) scale that asks both about occurrence of presumed rewarding events and their anticipated pleasantness. Our RE scale will ask participants to rate 58 items on frequency in the last week as well perceived/expected pleasantness of events. Secondary measures include the 18-item Apathy Evaluation Scale (AES), the Temporal Experience of Pleasure (TEPS), Minnesota Nicotine Withdrawal Scale-Revised (MNWS), and a measure of delay discounting (DD).

NCT01824511
Patrocinador PrincipalUniversity of Vermont
Última actualización: 14 de marzo de 2016
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 287 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 permitidos

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

Condiciones

Patología

Enfermedades del sistema nerviosoManifestaciones NeurológicasSignos y SíntomasCondiciones Patológicas, Signos y Síntomas

Criterios

Inclusion Criteria: For all participants: 18 yrs old or older able to read and understand verbal English fluently citizen or resident alien agree to abstain from illegal drugs during the study For current smokers: currently smoke >10 cigarettes daily for > 1 yr want to quit smoking for good via abrupt cessation without treatment willing to quit 7-14 days from study entry and not reduce before quitting no reduction in cigs/day by >25% in the last month agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study have carbon monoxide (CO) level > or = 8 ppm at the time of consent no current use of prescribed psychoactive medications, including smoking cessation products. For former smokers: smoked >10 cigarettes daily for > 1 yr quit at least 1 yr ago use of cigarettes or e-cigarettes 5 or fewer times in past year no tobacco or nicotine-containing product in last month agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study have carbon monoxide (CO) level < 8 ppm at the time of consent no current use of prescribed psychoactive medications, including smoking cessation products. Exclusion Criteria for all participants: History of hand or wrist problems that could be exacerbated by study participation or interferes with completion of tasks current (last year) mood or alcohol/drug-related psychiatric disorder or any neurological condition that could influence reward sensitivity; e.g. Parkinsonism used marijuana 2 or more times in the last month problems with the use of alcohol or illegal drugs in the last 6 months currently pregnant use of smokeless tobacco lacking the use of one or both hands

Plan de Estudio

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

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Participants are paid to quit smoking without using any medications.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

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 2 ubicaciones

Dartmouth College

Hanover, United StatesAbrir Dartmouth College en Google Maps

University of Vermont

Burlington, United States
Completado2 Centros de Estudio