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Effects of Quitting Study A Test of Pre-clinical Findings

11 de marzo de 2016 actualizado por: John Hughes, University of Vermont

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

The most widely-accepted animal model of nicotine withdrawal states stopping nicotine makes rewarding events become less rewarding. The current study will test if this is true in humans. If we find tobacco abstinence does make rewards less rewarding, this would suggest new symptoms to add to official descriptions of nicotine withdrawal. It would also suggest we need to develop new behavioral and pharmacological interventions to correct this problem. If stopping smoking does not make rewards less rewarding, this would suggest this animal model does not apply to the human condition and we need to continue to search for an animal model of tobacco withdrawal that is relevant to smokers stopping smoking.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Actual)

287

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 Hampshire
      • Hanover, New Hampshire, Estados Unidos, 03755
        • Dartmouth College
    • Vermont
      • Burlington, Vermont, Estados Unidos, 05401
        • University of Vermont

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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:

  1. currently smoke >10 cigarettes daily for > 1 yr
  2. want to quit smoking for good via abrupt cessation without treatment
  3. willing to quit 7-14 days from study entry and not reduce before quitting
  4. no reduction in cigs/day by >25% in the last month
  5. agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
  6. have carbon monoxide (CO) level > or = 8 ppm at the time of consent
  7. no current use of prescribed psychoactive medications, including smoking cessation products.

For former smokers:

  1. smoked >10 cigarettes daily for > 1 yr
  2. quit at least 1 yr ago
  3. use of cigarettes or e-cigarettes 5 or fewer times in past year
  4. no tobacco or nicotine-containing product in last month
  5. agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
  6. have carbon monoxide (CO) level < 8 ppm at the time of consent
  7. 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 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: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Smokers Cease Smoking
Participants are paid to quit smoking without using any medications.
Smokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Responses to Effort Expenditure for Rewards Task (EEfRT) Test
Periodo de tiempo: four weeks after quit date
The primary outcome will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task.
four weeks after quit date
Rewarding Events Scale score.
Periodo de tiempo: four weeks after quit date
The score on our Rewarding Events scale.
four weeks after quit date

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Delayed Discounting
Periodo de tiempo: four weeks after quit date
Measures preference for immediate vs. delayed rewards by responses to several scenarios. Outcome is a statistic that describes relative preference by time to reward.
four weeks after quit date
Self-reports of Anhedonia and Apathy
Periodo de tiempo: four weeks after quit date
Temporal Experience of Pleasure (TEPS) and Apathy Evaluation Scale (AES) both ask participants to rate pleasantness of common rewards. Outcome is mean rating on ordinal scales. Positive and Negative Affect Scale (PANAS) and the Minnesota Nicotine Withdrawal Scale-Revised (MNWS) ask participants to rate several mood or nicotine withdrawal symptoms. Outcome is mean rating on 4 or 5 point ordinal scale.
four weeks after quit date

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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 abril de 2013

Finalización primaria (Actual)

1 de septiembre de 2015

Finalización del estudio (Actual)

1 de septiembre de 2015

Fechas de registro del estudio

Enviado por primera vez

1 de abril de 2013

Primero enviado que cumplió con los criterios de control de calidad

1 de abril de 2013

Publicado por primera vez (Estimar)

4 de abril de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de marzo de 2016

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

11 de marzo de 2016

Última verificación

1 de marzo de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CHRBS B11-185
  • R01DA031687 (Subvención/contrato del NIH de EE. UU.)

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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