- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01567943
Contingency Management of Alcohol Abuse in the Severely Mentally ILL (CMETG)
Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The contingency management (CM) paradigm that will be used is the variable magnitude of reinforcement procedure. In order to encourage engagement in study procedures and reduce dropout in the randomized sample, all participants will undergo a 4-week pre-randomization induction period. During the induction period, participants will be reinforced for providing urine-tests three times a week. Those who demonstrate study participation and need for treatment during the induction period will be randomized to receive treatment as usual and either 1) 12 weeks of CM for alcohol abstinence (assessed by Ethyl glucuronide immunoassay urine-test) AND weekly reinforcement for intensive outpatient addiction treatment attendance; or 2) 12 weeks of reinforcement for providing urine-samples and continued study involvement. Randomization will be used to assign participants to treatment conditions.
The primary outcome will be changes in alcohol use assessed by Ehyl glucuronide immunoassay urine-tests, breath-tests, as well as self- and clinician-reported alcohol use. The secondary outcome will be changes in intensive outpatient group attendance assessed by intensive outpatient clinician-report, as well as administrative data sources, and self-report. Other outcomes will include: urine-tests and self-reported illicit drug use, psychiatric symptoms, other outpatient treatment utilization, HIV-risk, and nicotine use. All outcomes will be assessed [for 4-weeks prior to study enrollment (self-report, clinician ratings etc)] and throughout the 4-week induction, 12-week intervention, and 3-month follow-up periods.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Washington
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Seattle, Washington, Estados Unidos, 98014
- Harborview Medical 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:
- Currently receiving psychiatric [AND intensive outpatient addiction treatment] at Community Psychiatric Clinic (CPC).
- Aged 18 to 65 years.
- Ability to understand written and spoken English language.
- DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview.
- Diagnosis of current serious mental illness: schizophrenia, schizoaffective disorders, bipolar disorder I or II, or recurring major depressive disorders as assessed by the MINI psychiatric interview.
- Alcohol use in the month prior to study entry: self-reported alcohol use of 5 days or more during the 30 days prior to study entry (5 drinking days/month is selected based on previous research reporting alcohol use in 18% of days assessed in a sample of psychiatric outpatients with co-occurring SUDs & SMI).120
- A CPC treating clinician must affirm the potential participant is safe to participate in the study.
Exclusion Criteria:
- A significant risk of dangerous alcohol withdrawal: a history of alcohol detoxification or seizure in the last 12 months AND participant or clinician concern that abstinence will induce dangerous alcohol withdrawal.
- DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI interview.
- Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
- Chart defined organic brain disorder or dementia.
- Inability to provide informed consent as measured by the University of California San Diego Brief Assessment of Capacity to Consent (UBACC), a tool designed to screen for ability to provide informed consent for research. If indicated by the UBACC screening process, the more comprehensive MacCAT-CR will be used.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Contingency Management
Contingency Management plus treatment as usual
|
Behavioral reinforcement for alcohol abstinence
|
Sin intervención: Non-contingent control group
Treatment as usual plus reinforcement for attendance
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine
Periodo de tiempo: Over 16 weeks of treatment (repeated measure)
|
Mean EtG value (in ng/mL).
150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative.
EtG = ethyl glucuronide, alcohol biomarker detectable in urine.
|
Over 16 weeks of treatment (repeated measure)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Intensive Outpatient Substance Abuse Treatment Attendance
Periodo de tiempo: During 16 weeks of treatment
|
During 16 weeks of treatment
|
|
Self Report Drug Use
Periodo de tiempo: through 7 months of study
|
through 7 months of study
|
|
Other Drug Use as Measured by Urinalysis
Periodo de tiempo: through 7 months of study
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through 7 months of study
|
|
Community Outcomes
Periodo de tiempo: entire study period, and three month prior and after study involvement
|
(jail bookings, ER visits, mental health and substance abuse service utilization)
|
entire study period, and three month prior and after study involvement
|
Psychiatric Symptomology
Periodo de tiempo: throughout 7 months of study
|
Brief Symptom Inventory; Positive and Negative Symptom Scale
|
throughout 7 months of study
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Richard K Ries, MD, University of Washington
- Investigador principal: Michael McDonell, PhD, Washington State University
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 (Actual)
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
- Síntomas de comportamiento
- Desordenes mentales
- Trastornos inducidos químicamente
- Procesos Patológicos
- Trastornos relacionados con el alcohol
- Trastornos relacionados con sustancias
- Trastornos del estado de ánimo
- Espectro de esquizofrenia y otros trastornos psicóticos
- Trastornos bipolares y relacionados
- Alcoholismo
- Depresión
- Desorden depresivo
- Esquizofrenia
- Enfermedad
- Trastorno bipolar
- Trastorno Depresivo Mayor
Otros números de identificación del estudio
- 41552-G
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
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