- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03227679
Metabolism-informed Care for Smoking Cessation
20 de julio de 2017 actualizado por: Hilary Tindle, Vanderbilt University Medical Center
Nicotine mediates smoking's addictive effects in the brain.
The ratio of 3-hydroxycotinine to cotinine, known as the nicotine metabolite ratio, or NMR, is a genetically- informed biomarker reflecting hepatic CYP2A6 activity and the rate of nicotine metabolism.
In light of a recent randomized controlled trial (RCT) in humans in Lancet Respiratory Medicine, which found that the NMR can be used to individualize treatment for smokers, our pilot study aims to determine the feasibility of using NMR to guide selection of pharmacotherapy in clinical populations of daily smokers.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Consenting participants will be assigned to guideline-based care (GBC: incorporating national guidelines and more recent evidence from clinical trials of pharmacotherapy for smoking cessation) or metabolism-informed care (MIC: identical to GBC but selection of medication based on NMR result).
All participants received counseling from a nurse level certified tobacco counseling.
After consent, participants undergo a blood draw for NMR, complete a baseline questionnaire, and are randomized to GBC or MIC.
At approximately 1, 3, and 6 months post-consent, participants will provide follow up information via telephone questionnaire regarding symptoms, confidence in quitting, use of medications, and smoking status.
At the 6-month follow-up time point, if a participant self-reports abstinence from smoking, the participant will be asked to complete a survey in-person and provide a sample of end-expired carbon monoxide for biochemical validation.
At the 6 month time point, GBC participants who continue to smoke will be offered an additional phone call from the nurse tobacco counselor in which the results of the baseline NMR test will be given, along with a second prescription for a smoking cessation medication based on the NMR results (i.e., single arm crossover design).
Two weeks after this additional phone call, the patient will be contacted for a final survey regarding use of medication and smoking status.
Tipo de estudio
Intervencionista
Inscripción (Actual)
82
Fase
- No aplica
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
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 18 years or older
- Smokes ≥ 5 cigarettes per day
- Willing to give up all forms of tobacco (5/10/2016 - 6/27/2016)
- Medically cleared (i.e., no contraindications in Section 3) to receive at least 2 FDA- approved smoking cessation medications
- Willing to use the medications for which medically cleared (individually, not in combination; only applicable if Medically Cleared = Yes)
Exclusion Criteria:
- Current diagnosis of schizophrenia, psychosis, active suicidal ideation, dementia, or severe mental retardation
- Receiving palliative or hospice care
- Currently pregnant or breastfeeding
- Hospitalized for a psychiatric condition in the past year (5/10/2016 - 6/27/2016)
- Hospitalized for a psychiatric condition in the past 3 months or change in psychiatric medications in last 3 months (6/28/2016 forward)
- Telephone problems that would preclude participation (e.g., can't receive calls reliably)
- Not able to read and speak English
- Abstinent from cigarettes for >3 days (b/c NMR not reliable after 72 hours)
- Used smoking cessation medications in the last 7 days (5/10/2016 - 6/27/2016)
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Metabolism-Informed Care (MIC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) recommendations were guided by Nicotine Metabolism as measured by the Nicotine Metabolite Ratio.
Ultimately, after being educated about smoking cessation medication efficacy and side-effects, the participant could decide to take any medication for which they were medically cleared, but the recommendation was made based on rate of Nicotine Metabolism.
|
This intervention used information from a genetically-informed biomarker (Nicotine Metabolite Ratio, NMR) to assign one of 3 FDA-approved smoking cessation pharmacotherapies (varenicline, bupropion, or NRT) to participants.
Farmacoterapia para dejar de fumar aprobada por la FDA
Otros nombres:
FDA-approved smoking cessation pharmacotherapy
Otros nombres:
Farmacoterapia para dejar de fumar aprobada por la FDA
Otros nombres:
|
Comparador activo: Guideline-Based Care (GBC)
Smoking Cessation Pharmacotherapy (varenicline, bupropion, and nicotine patch) was co-selected from those they were medically able to receive after educating participants about smoking cessation medication efficacy and side-effects.
|
Farmacoterapia para dejar de fumar aprobada por la FDA
Otros nombres:
FDA-approved smoking cessation pharmacotherapy
Otros nombres:
Farmacoterapia para dejar de fumar aprobada por la FDA
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Theoretical Endorsement of MIC as assessed by level of agreement to a set of seven 5-point Likert Scale questions
Periodo de tiempo: Baseline
|
Likert Scale from Strongly Disagree to Strongly Agree on items assessing attitudes toward and perceptions of using metabolism information to guide medical care
|
Baseline
|
Acceptance of MIC medication recommendation as assessed by concordance between MIC recommendation and actual prescribed medication
Periodo de tiempo: At 4 weeks post-baseline
|
Level of agreement between participant's prescribed medication and the medication that would be recommended based on Nicotine Metabolite Ratio
|
At 4 weeks post-baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Confidence in Quitting
Periodo de tiempo: Baseline - 6 months
|
Self-reported confidence in ability to quit
|
Baseline - 6 months
|
Medication Use/Compliance
Periodo de tiempo: 1 - 6 months
|
Use of prescribed medication, as directed
|
1 - 6 months
|
Smoking Status
Periodo de tiempo: 6 months
|
Self-reported and/or biochemically validated smoking cessation
|
6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Quinn Wells, MD, Vanderbilt University Medical Center
- Investigador principal: Dawn Beaulieu, MD, Vanderbilt University Medical Center
- Investigador principal: Matthew Freiberg, MD, Vanderbilt University Medical Center
- Investigador principal: Hilary Tindle, MD, Vanderbilt University Medical Center
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.
Publicaciones Generales
- World Health Organization. Assessment of the Economic Costs of Smoking. Economics of tobacco toolkit. 2011;:1-116.
- Agaku IT, King BA, Dube SR; Centers for Disease Control and Prevention (CDC). Current cigarette smoking among adults - United States, 2005-2012. MMWR Morb Mortal Wkly Rep. 2014 Jan 17;63(2):29-34.
- Benowitz NL. Pharmacology of nicotine: addiction, smoking-induced disease, and therapeutics. Annu Rev Pharmacol Toxicol. 2009;49:57-71. doi: 10.1146/annurev.pharmtox.48.113006.094742.
- Hukkanen J, Jacob P 3rd, Benowitz NL. Metabolism and disposition kinetics of nicotine. Pharmacol Rev. 2005 Mar;57(1):79-115. doi: 10.1124/pr.57.1.3.
- Chen LS, Bloom AJ, Baker TB, Smith SS, Piper ME, Martinez M, Saccone N, Hatsukami D, Goate A, Bierut L. Pharmacotherapy effects on smoking cessation vary with nicotine metabolism gene (CYP2A6). Addiction. 2014 Jan;109(1):128-137. doi: 10.1111/add.12353. Epub 2013 Nov 11.
- Dempsey D, Tutka P, Jacob P 3rd, Allen F, Schoedel K, Tyndale RF, Benowitz NL. Nicotine metabolite ratio as an index of cytochrome P450 2A6 metabolic activity. Clin Pharmacol Ther. 2004 Jul;76(1):64-72. doi: 10.1016/j.clpt.2004.02.011.
- Lerman C, Schnoll RA, Hawk LW Jr, Cinciripini P, George TP, Wileyto EP, Swan GE, Benowitz NL, Heitjan DF, Tyndale RF; PGRN-PNAT Research Group. Use of the nicotine metabolite ratio as a genetically informed biomarker of response to nicotine patch or varenicline for smoking cessation: a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2015 Feb;3(2):131-138. doi: 10.1016/S2213-2600(14)70294-2. Epub 2015 Jan 12.
- Hughes JR, Stead LF, Hartmann-Boyce J, Cahill K, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2014 Jan 8;2014(1):CD000031. doi: 10.1002/14651858.CD000031.pub4.
- Bauld L, Bell K, McCullough L, Richardson L, Greaves L. The effectiveness of NHS smoking cessation services: a systematic review. J Public Health (Oxf). 2010 Mar;32(1):71-82. doi: 10.1093/pubmed/fdp074. Epub 2009 Jul 28.
- 2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.
- Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.
- Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016 Jun 18;387(10037):2507-20. doi: 10.1016/S0140-6736(16)30272-0. Epub 2016 Apr 22.
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 (Actual)
18 de mayo de 2016
Finalización primaria (Actual)
8 de octubre de 2016
Finalización del estudio (Actual)
18 de abril de 2017
Fechas de registro del estudio
Enviado por primera vez
29 de junio de 2017
Primero enviado que cumplió con los criterios de control de calidad
20 de julio de 2017
Publicado por primera vez (Actual)
24 de julio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
20 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes colinérgicos
- Inhibidores de enzimas
- Drogas psicotropicas
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes antidepresivos
- Agentes de dopamina
- Inhibidores de enzimas del citocromo P-450
- Estimulantes ganglionares
- Agonistas nicotínicos
- Agonistas colinérgicos
- Agentes antidepresivos, segunda generación
- Inhibidores del citocromo P-450 CYP2D6
- Inhibidores de la captación de dopamina
- Nicotina
- Bupropión
- Vareniclina
Otros números de identificación del estudio
- 160512
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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. .
Ensayos clínicos sobre El consumo de tabaco
-
Nanfang Hospital of Southern Medical UniversityShenzhen People's Hospital; Second Affiliated Hospital of Guangzhou Medical UniversityAún no reclutandoLesiones Pancreáticas Sólidas | USE-FNB
-
Asan Medical CenterDesconocidoUSE-PAAF | CitodiagnósticoCorea, república de
-
Milton S. Hershey Medical CenterNational Cancer Institute (NCI)Activo, no reclutandoQuiste pancreático | USE-PAAFEstados Unidos
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityTerminadoCáncer de recto | USE-PAAF | Pathological Complete RemissionPorcelana
-
National Cheng-Kung University HospitalDesconocidoMétodo de succión húmeda basado en heparina en EUS Biopsia con aguja fina de masa pancreática sólidaNeoplasias pancreáticas | Ultrasonografía endoscópica | USE-PAAFTaiwán