Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
Buprenorphine soluble film
+ Placebo
+ Buprenorphine/naloxone film strip
Trastornos Relacionados con Narcóticos
+ Trastornos Mentales
+ Trastornos relacionados con los opioides
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2008
Fecha en la que se inscribió al primer participante.Buprenorphine sublingual and buccal soluble films are being developed to be used for the same indication and over the same buprenorphine dose range as Subutex and Suboxone sublingual tablets in the treatment of opioid dependence. However, only films administered by the sublingual route were evaluated in this study. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Subutex and Suboxone product: * Mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format. * Improvement in subject convenience and compliance by ensuring rapid disintegration. * Protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting. * Provision of a unit dose product format for hospital and institutional use. * Decreased product damage during shipping as compared to Subutex and Suboxone tablets.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 38 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 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Subject must: * Provide written informed consent. * Have a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of opioid dependence. * Be male or female, 18 to 65 years of age, inclusive. * If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control. Exclusion Criteria: Subjects must not: * Have participated in an experimental drug or device study within the last 30 days. * Be currently (past 30 days from start of screening) engaged in opioid agonist, opioid partial agonist, or opioid antagonist treatment. * If female, be breast feeding or lactating. * Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study. * Have any clinically significant non-substance use psychiatric disorder (e.g., schizophrenia). * Have current suicidal ideation. * Have a Mini Mental Status Exam score less than 24. * Have physical dependence on alcohol. * Have physical dependence on sedative-hypnotics. * Have active aphthous stomatitis. * Have active oral herpes. * Need on-going prescription medications that interact with the P450 3A4 (a member of the cytochrome P450 superfamily of enzymes) system.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos 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
Johns Hopkins University School of Medicine
Baltimore, United StatesAbrir Johns Hopkins University School of Medicine en Google Maps