- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01824511
Effects of Quitting Study A Test of Pre-clinical Findings
Does Smoking Cessation Increase Anhedonia? A Test of Pre-clinical Findings
Descripción general del estudio
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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Hampshire
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Hanover, New Hampshire, Estados Unidos, 03755
- Dartmouth College
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- University of Vermont
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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:
- 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 estudios
¿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 |
|---|---|
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Experimental: Smokers Cease Smoking
Participants are paid to quit smoking without using any medications.
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Smokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Responses to Effort Expenditure for Rewards Task (EEfRT) Test
Periodo de tiempo: four weeks after quit date
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The primary outcome will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task.
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four weeks after quit date
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Rewarding Events Scale score.
Periodo de tiempo: four weeks after quit date
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The score on our Rewarding Events scale.
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four weeks after quit date
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Delayed Discounting
Periodo de tiempo: four weeks after quit date
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Measures preference for immediate vs. delayed rewards by responses to several scenarios.
Outcome is a statistic that describes relative preference by time to reward.
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four weeks after quit date
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Self-reports of Anhedonia and Apathy
Periodo de tiempo: four weeks after quit date
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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.
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four weeks after quit date
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHRBS B11-185
- R01DA031687 (Subvención/contrato del NIH de EE. UU.)
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