Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients
Colección de datos
Trastornos Relacionados con Narcóticos
+ Trastornos Mentales
+ Trastornos relacionados con los opioides
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 1994
Fecha en la que se inscribió al primer participante.This 27-week double-blind, placebo controlled treatment is designed to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients. All subjects will receive methadone. For the treatment of cocaine dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or placebo. After 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or 60mg). This dose is maintained for 20 weeks; during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy. Follow up evaluations will be conducted out to 3 months post treatment. Subjects will be assisted in transferring to Houston area methadone clinics to maintain treatment for opiate dependence following treatment completion.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 140 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 45 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
Criterios
Inclusion Criteria- Subject must: * Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID. * Be between 18 and 45 years old * Women must agree to use contraception * Have an EKG that has been confirmed by a cardiologist * Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal Exclusion Criteria- Subject must not: • Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent * Have any Axis I disorder that is not related to drug use * Have current dependence on any psychoactive disorder other than nicotine * Be on probation or parole for reasons other than those related to drug charges (ASI) * Be pregnant or lactating * Have been in any outside treatment in 3 months
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.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 una ubicación
University of Texas Health Science Center
Houston, United StatesAbrir University of Texas Health Science Center en Google Maps