Preventing Drug Use in Low Income Clinic Populations (QUIT)
16 de noviembre de 2016 actualizado por: University of California, Los Angeles
The proposed study will address the critical need to reduce illegal drug use, in particular drug use, and the occurrence of drug-related harm in low-income racially diverse patient populations at urban primary care safety-net clinics.
Since they are at risk for accelerated trajectories to drug dependence once drug use begins, low-income racially diverse populations pose particular concern for public health policy makers and drug-use prevention efforts.
The study will be the first to standardize drug screening and primary-care clinician delivered brief intervention among racially diverse "at risk" drug users, that is users with casual or frequent use without the physiological or psychological manifestations of dependence, to reduce their 'at risk' use of drugs, and it may effectively interrupt their pathway to dependence.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The Quit Using Drugs Intervention Trial (QUIT) will be the first randomized controlled trial in the U.S. that is powered to detect the effect of a primary care clinician delivered brief intervention protocol for reducing 'at risk' drug use and drug-related harm among low-income adult patients (ages 18 and older) at multiple safety net clinics in Los Angeles County.
For this small trial, we will sample patients with 'at risk' use of drugs (marijuana, crack/cocaine, amphetamines/methamphetamines, inhalants, sedatives or sleeping pills, hallucinogens, and opiates), the most commonly used serious drugs among patients at our clinic sites.
"At risk" drug use is defined in this study as current use (past 90 days) of drug measured as a self-reported total score of 4 to 26 on the WHO Alcohol Substance Involvement Screening Test (ASSIST).
A total of 7,000-8,000 patients will be approached for screening to yield a 3-month effective sample size of 245 eligible patients per condition (1) an intervention condition involving drug use health education or (2) a control condition involving care as usual.
In the intervention condition, very brief (less than 5 minutes) clinician advice regarding quitting drug use will be followed by two 2 and 6 week post-visit drug health education sessions on quitting drug use and cautioning against use of other 'at risk' substance use such as alcohol and tobacco.
Patients assigned to the control condition will receive standard care for drug use at the baseline visit with their clinician.
Follow-up assessments will be conducted at 3 month post-randomization.
The framework for the QUIT project is the Social Action Theory, and the brief intervention protocol is based on NIDA's principles on prevention research and the utility of the 5 A's approach for assisting behavioral changes among patients (Ask, Advise, Assess, Assist, Arrange) in the clinic setting.
If found to be effective in the community health center setting, this clinician and telephone drug-use health education program could become a model for health promotion activities.
that would be expanded to all 'at risk' substance use and shared between community health centers.
Tipo de estudio
Intervencionista
Inscripción (Actual)
411
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90024
- UCLA
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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
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- ages 18 and older
- report of drug use in the previous 90 days (i.e., (marijuana, crack/cocaine, amphetamines/methamphetamines, inhalants, sedatives or sleeping pills, hallucinogens, and opiates)
- an ASSIST score between 4 and 26 indicating 'at risk' drug use
- English or Spanish speaking
- able (not cognitively impaired) and willing to cooperate with data collection and research procedures, including 2 telephone counseling sessions and 3 month follow-up assessments
Exclusion Criteria:
- Pregnant
- Drug or alcohol dependence
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention
The Quit Using Drugs Intervention Trial (QUIT) experimental arm includes: screening, very brief clinician advice, and telephone drug-use health education to reduce 'at risk' drug use and thus interrupt progression from casual or episodic abuse to dependence.
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The goal of the Quit Using Drugs Intervention Trial (QUIT) is to conduct a small RCT of a primary care clinic-based very brief intervention protocol for reducing the use of illegal drugs and the occurrences of drug-related harm in low-income, racially-diverse patient populations at two 'safety-net' clinics in Los Angeles.
The design will emphasize screening, very brief clinician advice, and telephone drug-use health education to reduce 'at risk' drug use and thus interrupt progression from casual or episodic abuse to dependence.
Otros nombres:
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Comparador falso: Control
This arm will receive a sham telephone intervention of equivalent duration on health behavior maintenance.
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This attention-control arm will receive a sham telephone intervention of equivalent duration on health behavior maintenance.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change from Baseline of Self-reported number of drug-free days at 3 month
Periodo de tiempo: past 30 and 90 days
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past 30 and 90 days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Decrease in drug-related harm (e.g., unemployment and job absenteeism, poor social support, poor health-related quality of life, HIV risk behaviors, motor vehicle accidents, and inpatient health services utilization).
Periodo de tiempo: 6 and 12 months post randomization
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6 and 12 months post randomization
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Lillian Gelberg, MD, MSPH, UCLA Department of Family Medicine
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
- Gelberg L, Andersen RM, Afifi AA, Leake BD, Arangua L, Vahidi M, Singleton K, Yacenda-Murphy J, Shoptaw S, Fleming MF, Baumeister SE. Project QUIT (Quit Using Drugs Intervention Trial): a randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use. Addiction. 2015 Nov;110(11):1777-90. doi: 10.1111/add.12993.
- Baumeister SE, Gelberg L, Leake BD, Yacenda-Murphy J, Vahidi M, Andersen RM. Effect of a primary care based brief intervention trial among risky drug users on health-related quality of life. Drug Alcohol Depend. 2014 Sep 1;142:254-61. doi: 10.1016/j.drugalcdep.2014.06.034. Epub 2014 Jul 4.
- Bone CW, Goodfellow AM, Vahidi M, Gelberg L. Prevalence of Sexual Violence and its Association with Depression among Male and Female Patients with Risky Drug Use in Urban Federally Qualified Health Centers. J Urban Health. 2018 Feb;95(1):111-115. doi: 10.1007/s11524-017-0213-7.
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
1 de enero de 2011
Finalización primaria (Actual)
1 de febrero de 2013
Finalización del estudio (Actual)
1 de febrero de 2013
Fechas de registro del estudio
Enviado por primera vez
6 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
10 de septiembre de 2013
Publicado por primera vez (Estimar)
16 de septiembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de noviembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
16 de noviembre de 2016
Última verificación
1 de noviembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- DESPR DA022445
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