- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00369408
Targeted Naltrexone for Problem Drinkers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a 12-week, placebo-controlled trial of naltrexone (50 mg orally) in 163 problem drinkers. Problem drinkers are those individuals whose drinking puts them at risk of a variety of psychosocial and medical problems, including alcohol dependence, but who are not physically dependent on alcohol. They are estimated to comprise up to 20% of the general population. The study employed a factorial design in which the effects of medication (naltrexone vs. placebo), schedule of medication administration (i.e., daily vs. targeted), and the interaction of these factors on drinking behavior were examined. Targeted administration refers to the use of medication to cope with anticipated high-risk drinking situations.
The daily monitoring using interactive voice response technology of mood, desire to drink, perceived self-efficacy, and drinking behavior will make it possible to examine in depth the processes by which the study variables exert their effects. Daily monitoring was performed using automated telephone interviews, with in-person follow-up evaluations conducted at 3 and 6 months post-treatment to provide a measure of the durability of treatment effects.
A pharmacogenetic analysis based on preliminary evidence showing that a functional polymorphism in the gene encoding the mu-opioid receptor (OPRM1) affects response to naltrexone will serve to explore an important source of variation in the response to naltrexone treatment. Exploratory analyses involving other potential genetic moderators of the response to naltrexone, such as the gene encoding the delta opioid receptor (OPRD1), will also be conducted, as will the correlation of genotype data with other phenotypes.
Careful evaluation of the study hypotheses will provide important information on the efficacy and mechanism of the effects of targeted naltrexone in problem drinkers. This study will allow us to model effects across multiple levels of analysis in an effort to understand the psychopharmacological mechanisms underlying the therapeutic effects of naltrexone in problem drinkers and to apply novel genetic findings to understanding the pharmacogenetic mechanisms underlying the therapeutic effects of naltrexone in problem drinkers.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06030
- University of Connecticut Health Center
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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:
- Male and female outpatients 18-70 years of age.
- Participants will have an average weekly ethanol consumption of >=24 standard drinks for men, or >=18 standard drinks for women (i.e., substantially in excess of non-hazardous drinking levels).
- Participants will be able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
- If a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or who are less than two years postmenopausal), participant must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment.
- Participants will be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels).
Exclusion Criteria:
- Participants who have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including total bilirubin elevations of >110% or ALT or AST elevations >300% the upper limit of normal or have a diagnosis of Hepatitis B or C infection or AIDS (given the potential for adverse effects of naltrexone on liver function).
- Participants who have a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality states, organic mood or mental disorders, or substantial suicide or violence risk) on the basis of history or psychiatric examination.
- Participants who have a current Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) diagnosis of drug dependence (other than nicotine dependence) or a lifetime DSM-IV diagnosis of opioid dependence.
- Participants who have a current DSM-IV diagnosis of alcohol dependence that is clinically severe.
- Participants who have used opioids or other psychoactive medications regularly in the month prior to study enrollment.
- Participants who have a history of hypersensitivity to naltrexone.
- Participants who are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 1
naltrexone (50 mg orally) for 12-week treatment period
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naltrexone (50 mg orally) for 12-week treatment period; 3 and 6 months post-treatment follow-up
Otros nombres:
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Comparador de placebos: 2
placebo for 12-week treatment period
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placebo for 12-week treatment period; 3 and 6 months post-treatment follow-up
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Drinking days and heavy drinking days
Periodo de tiempo: 12-week trial; 3 and 6 months post-treatment follow-up
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12-week trial; 3 and 6 months post-treatment follow-up
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Alcohol-related problems
Periodo de tiempo: 12-week trial; 3 and 6 months post-treatment follow-up
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12-week trial; 3 and 6 months post-treatment follow-up
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Biological measures of alcohol consumption (i.e., serum GGTP and CDT)
Periodo de tiempo: 12-week trial; 3 and 6 months post-treatment follow-up
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12-week trial; 3 and 6 months post-treatment follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Henry R. Kranzler, MD, University of Pennsylvania
Publicaciones y enlaces útiles
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
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos inducidos químicamente
- Comportamiento de bebida
- Trastornos relacionados con el alcohol
- Trastornos relacionados con sustancias
- Consumo de alcohol
- Alcoholismo
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Agentes del sistema sensorial
- Antagonistas de narcóticos
- Disuasivos de alcohol
- Naltrexona
Otros números de identificación del estudio
- 03-107-2
- NIAAA-KRA-P50-03510
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 Consumo de alcohol
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Karolinska InstitutetTerminadoConsumo de alcohol | Dependencia al alcohol | Alcohol; Uso nocivo | Trastorno por consumo de alcohol | Abuso de alcoholSuecia
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Charles Drew University of Medicine and ScienceRetiradoConsumo de alcohol | Trastorno por consumo de alcohol | Abuso de alcohol | Problema de alcohol
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University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyTerminadoBebiendo alcohol | Consumo, AlcoholNueva Zelanda
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Karolinska InstitutetRegion StockholmTerminadoDependencia al alcohol | Trastorno por consumo de alcohol | Abuso de alcohol | Uso nocivo de alcoholSuecia
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HBSAReclutamientoConsumo excesivo de alcohol, consumo de alcohol por menores de edad, beber y conducir, daños relacionados con el alcoholEstados Unidos
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Boston Medical CenterBoston University; National Institute on Alcohol Abuse and Alcoholism (NIAAA)TerminadoDependencia al alcohol | Abuso de alcohol | Uso no saludable de alcohol | Cantidades peligrosas de consumo de alcohol | Uso peligroso de alcoholEstados Unidos
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University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Activo, no reclutandoAlcohol; uso, problemaEstados Unidos
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University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)TerminadoAlcohol; uso, problemaEstados Unidos
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University of Central FloridaInscripción por invitación
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University of ThessalyEuropean Social FundTerminadoDependencia al alcohol | Trastorno por consumo de alcohol | Consumo excesivo de alcohol | Abuso de alcohol
Ensayos clínicos sobre Naltrexone
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University of California, San FranciscoTerminadoEsclerosis múltipleEstados Unidos