Buprenorfina para personas en libertad condicional y en libertad condicional: Cerrar la brecha hacia el tratamiento
This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program. Project implementation will occur at Guilford Avenue, the primary intake unit for Baltimore City Community Supervision (Probation and Parole). The proposed study is a parallel two-group randomized controlled trial in which 160 men and 160 women with OUD on community supervision in Baltimore will be randomly assigned within community supervision status (probation or parole) and gender to one of two treatment conditions: (1) Buprenorphine Bridge Treatment (BBT): Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment; or (2) Treatment as Usual (TAU): Participants will receive a referral to buprenorphine treatment in the community. Both conditions will receive information on overdose prevention. Participants will be assessed at baseline, and 1, 2, 3, 6, and 12 months post-intake using a comprehensive assessment battery. The Primary Aim: To compare the relative effectiveness of BBT to TAU in terms of: (a) illicit opioid drug test (oral saliva) results. The Secondary Aim: To examine the extent to which BBT is superior to TAU in terms of: (b) number of days receiving opioid treatment; (c) number of days using illicit opioids; (d) quality of life (i. physical health; ii. mental health); (e) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); (f) criminal activity; (g) re-arrest; and (h) re-incarceration. The proposed study is significant because the large number of probationers/parolees with OUD have limited access to an efficacious treatment, buprenorphine pharmacotherapy. The proposed study is innovative because it would be the first trial in the US assessing the effectiveness of interim buprenorphine initiated at a community supervision office compared to referral to a community treatment program. The public health impact would be widespread, as this model of care could be scaled-up throughout many areas of the US with criminal justice populations with high rates of OUD.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Maryland
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Baltimore, Maryland, Estados Unidos, 21202
- Division of Parole & Probation
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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:
- Subject must provide written informed consent prior to the conduct of any study-related procedures
- Male or female, 18-65 years of age, inclusive
- Be on parole or probation for at least the next 4 months
- Have a Baltimore City address, and (5) Primary diagnosis of (DSM-5) moderate-severe opioid use disorder (at least 4 symptoms) including current use and current physiologic dependence [Note: parolees not currently physically dependent will be allowed in the study].
Exclusion Criteria:
- Current medical condition that may prevent the participant from safely participating in the study as determined by medical evaluation
- Current psychosis or suicidal ideation
- Cognitive disorders that prevent the participant from passing a study enrollment quiz
- Any pending legal action that would interrupt study participation (eg, pending incarceration, probation/parole revocation, unadjudicated charges)
- Exposure to any investigational drug within 8 weeks of screening
- Current use benzodiazepines (such as Valium, Xanax and other sedatives), either prescribed or illicitly obtained
- Currently enrolled in a methadone maintenance treatment program or taking long-acting naltrexone.
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 |
|---|---|
|
Comparador activo: TAU
Participants will receive a referral to buprenorphine treatment in the community. |
Participants will receive a referral to buprenorphine treatment in the community
Otros nombres:
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|
Experimental: BBT
Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment |
Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
opioid use
Periodo de tiempo: 12 months
|
illicit opioid drug test (oral saliva) results |
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
treatment adherence
Periodo de tiempo: 12 months
|
entered community based treatment |
12 months
|
|
treatment adherence
Periodo de tiempo: 12 months
|
number of days receiving opioid treatment |
12 months
|
|
opioid use days
Periodo de tiempo: 12 months
|
number of days using illicit opioids |
12 months
|
|
health-related quality of life
Periodo de tiempo: 12 months
|
physical health using the SF-12 Health Survey |
12 months
|
|
health-related quality of life
Periodo de tiempo: 12 months
|
mental health using the SF-12 Health Survey |
12 months
|
|
HIV risk behaviors
Periodo de tiempo: 12 months
|
sexual behavior using the Risk Assessment Battery (RAB) |
12 months
|
|
HIV risk behaviors
Periodo de tiempo: 12 months
|
needle use or sharing using the Risk Assessment Battery (RB) |
12 months
|
|
criminal activity
Periodo de tiempo: 12 months
|
criminal activity days |
12 months
|
|
re-arrest
Periodo de tiempo: 12 months
|
time to re-arrest |
12 months
|
|
re-incarceration
Periodo de tiempo: 12 months
|
time to re-incarceration |
12 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
- Compuestos heterocíclicos
- Compuestos heterocíclicos, anillo fusionado
- Preparaciones farmacéuticas
- Alcaloides
- Hidrocarburos aromáticos policíclicos
- Compuestos policíclicos
- Compuestos heterocíclicos, 4 o más anillos
- Combinaciones de drogas
- Naloxona
- Morfinanos
- Alcaloides opiáceos
- Compuestos heterocíclicos, anillo puente
- Fenantrenos
- Buprenorfina
- Combinación de fármacos de buprenorfina y naloxona
- Terapéutica
Otros números de identificación del estudio
- FRI
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
FRI is committed to the open and timely dissemination of research outcomes. Investigators in the proposed activity recognize that promising new methods and strategies may arise during the course of the research. Fri will abide by the principles for sharing research resources as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. Working with the research community, as well as the federal funding agency, FRI will serve the scientific community at large by sharing ideas and software to ensure that new knowledge benefits society. Our goals are to disseminate new ideas so the public can benefit from discoveries, and to generate new ideas for research and education. Any data shared will be de-identified and follow the regulations set forth in applicable Human Subjects Protection Guidelines.
Marco de tiempo para compartir IPD
At completion of the study.
Criterios de acceso compartido de IPD
Contact Dr. Michael Gordon Friends Research Institute
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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