Buprenorfina para probatórios e liberdade condicional: preenchendo a lacuna no tratamento
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Maryland
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Baltimore, Maryland, Estados Unidos, 21202
- Division of Parole & Probation
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: TAU
Participants will receive a referral to buprenorphine treatment in the community. |
Participants will receive a referral to buprenorphine treatment in the community
Outros nomes:
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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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
opioid use
Prazo: 12 months
|
illicit opioid drug test (oral saliva) results |
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
treatment adherence
Prazo: 12 months
|
entered community based treatment |
12 months
|
|
treatment adherence
Prazo: 12 months
|
number of days receiving opioid treatment |
12 months
|
|
opioid use days
Prazo: 12 months
|
number of days using illicit opioids |
12 months
|
|
health-related quality of life
Prazo: 12 months
|
physical health using the SF-12 Health Survey |
12 months
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|
health-related quality of life
Prazo: 12 months
|
mental health using the SF-12 Health Survey |
12 months
|
|
HIV risk behaviors
Prazo: 12 months
|
sexual behavior using the Risk Assessment Battery (RAB) |
12 months
|
|
HIV risk behaviors
Prazo: 12 months
|
needle use or sharing using the Risk Assessment Battery (RB) |
12 months
|
|
criminal activity
Prazo: 12 months
|
criminal activity days |
12 months
|
|
re-arrest
Prazo: 12 months
|
time to re-arrest |
12 months
|
|
re-incarceration
Prazo: 12 months
|
time to re-incarceration |
12 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Compostos heterocíclicos
- Compostos heterocíclicos, anel fundido
- Preparações farmacêuticas
- Alcalóides
- Hidrocarbonetos aromáticos policíclicos
- Compostos policíclicos
- Compostos heterocíclicos, 4 ou mais anéis
- Combinações de drogas
- Naloxona
- Morfinans
- Alcalóides de opiáceos
- Compostos heterocíclicos, anel em ponte
- Fenanthrenes
- Buprenorfina
- Buprenorfina, combinação de drogas naloxona
- Terapêutica
Outros números de identificação do estudo
- FRI
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Prazo de Compartilhamento de IPD
At completion of the study.
Critérios de acesso de compartilhamento IPD
Contact Dr. Michael Gordon Friends Research Institute
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
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