- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03586466
Improving Office Based Treatment of Opioid Use Disorder With Technology
Pilot for Improved Office Based Treatment of Opioid-Dependence
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The misuse and abuse of opioids is a serious public health problem. SAMHSA estimates that more than 12 million Americans misuse prescription opioids for nonmedical purposes annually. The costs of this problem are substantial, both to individuals and society: total costs of prescription opioid misuse, abuse, and overdose to the US is estimated at $78.5 billion annually. Additionally, the prevalence of opioid abuse and associated costs are on the rise. In spite of this, the availability and acceptance of treatment with medications has not kept pace with the spread of the epidemic.
Prescription of buprenorphine/naloxone (B/N) is intended to address a behavioral health issue (misuse of opioids) as a component of Medication Assisted Treatment (MAT) for those who are pharmacologically dependent on opioids. In chronic illness, patient compliance and adherence with a prescribed regimen has been shown to correlate with treatment success, and conversely poor patient compliance, commonly documented, correlates with poor outcomes. Studies have demonstrated that with B/N specifically, compliance is predictive of both relapse and treatment retention. Relapse events are costly in terms of total healthcare expenditures (around $15,000 per patient), and personally - upwards of 800,000 years of potential life lost before the age of 65 in the US alone.
This study seeks to examine the effectiveness of MedicaSafe's BupreCare system in the delivery of MAT to those with OUD. The BupreCare system is a connected, locking, oral medication dispenser and secure pill cartridges coupled with an online platform. The system is programmed with a treatment plan to allow for the dispensation of medications in the right dose at the right time. Dispensation is recorded and collated in treatment reports to track patient adherence to their regimen. The project intends to ameliorate issues associated with MAT by curbing the negative effects of medication nonadherence and diversion, while simultaneously increasing provider awareness of patient behaviors and needs.
Patients aged 18-65 (inclusive) will be enrolled at Friends Research Institute in a field trial. Patients will be maintained on a stable dose of B/N, and randomized into one of three arms (BupreCare, TAU, or TAU with MEMS tracking). Subjects will have bi-weekly study visits over the course of 12 weeks. Assessments will be collected at baseline, and then every 2 weeks following study initiation.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Caitlin Kelliher
- Número de telefone: 6466611092
- E-mail: caitlin.kelliher@medicasafe.com
Locais de estudo
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California
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San Diego, California, Estados Unidos, 92103
- Rescindido
- Artemis Institute for Clinical Research
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Recrutamento
- Friends Research Institute
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Contato:
- Kathy Couvillion, BA
- Número de telefone: 242 410-837-3977
- E-mail: kcouvillion@friendsresearch.org
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Investigador principal:
- Michael Gordon, DPA
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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:
- Be between the ages of 18 and 65 years old
- Be able to provide informed consent
- Be English-speaking
- Have consistent phone and/or internet access
- Deemed by physician as medically, psychiatrically, and otherwise appropriate for buprenorphine therapy
- Maintained on a stable B/N dose
Exclusion Criteria:
- Be younger than 18 or older than 65 years of age
- Chronic pain
- Be non-English speaking
- Be unable to complete informed consent
- Be pregnant
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 |
---|---|
Experimental: BupreCare
The BupreCare system is an integrated medication management and patient monitoring system, consisting of a smart medication-tracking dispenser and online platform.
The dispensing component is a portable smart dispenser and secure pill cartridges that is programmed with an individualized treatment plan for each patient.
This arm will be assigned a MedicaSafe device that will have their buprenorphine/naloxone securely stored.
Treatment reports of their dispensation history will be collated and available to the treatment team.
|
Subjects will receive their medication in a MedicaSafe device.
Medication will be dispensed in accordance with the programmed treatment plan for each subject.
Subjects will complete a "Check-In" remotely each week with their device.
Outros nomes:
Subjects will be given buprenorphine/naloxone as a component of Medication Assisted Treatment (MAT).
|
Comparador Ativo: Treatment as Usual
This arm represents an active comparator for the experimental group.
Subjects in this group will undergo TAU, with no changes to the way that they receive their medication.
They will have pill counts bi-weekly to examine adherence.
|
Subjects will be given buprenorphine/naloxone as a component of Medication Assisted Treatment (MAT).
|
Comparador Ativo: Treatment as Usual with MEMS
This arm represents a second active comparator for the experimental group.
Subjects in this group will receive their medication in a MEMS pill bottle, but otherwise will undergo TAU.
|
Subjects will be given buprenorphine/naloxone as a component of Medication Assisted Treatment (MAT).
Subjects will receive their medication in a MEMS pill bottle.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Compliance
Prazo: Compliance checks will be done every 14 days. Total compliance for each subject will be looked at across the 12-week period of participation.
|
Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken.
For BupreCare, this will be done using the treatment reports from the device.
For MEMS, this will be done with the data from the MEMS device.
For TAU, this will be done with pill counts.
Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment.
|
Compliance checks will be done every 14 days. Total compliance for each subject will be looked at across the 12-week period of participation.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Urine Drug Screens
Prazo: Bi-weekly, across the 12-week participation period.
|
Urine Drug Tests will be given at each in-person study visit to test for opiates and other illicit substances.
The proportion of negative urine samples (for opiates) will serve as a secondary endpoint.
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Bi-weekly, across the 12-week participation period.
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Relapse
Prazo: Examined bi-weekly across the 12-week participation period.
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This will be determined by opiate-positive Urine Drug Screens.
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Examined bi-weekly across the 12-week participation period.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Compliance - Week 4
Prazo: Week 4 of the 12-week participation period.
|
Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken.
For BupreCare, this will be done using the treatment reports from the device.
For MEMS, this will be done with the data from the MEMS device.
For TAU, this will be done with pill counts.
Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment.
|
Week 4 of the 12-week participation period.
|
Compliance - Week 8
Prazo: Week 8 of the 12-week participation period.
|
Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken.
For BupreCare, this will be done using the treatment reports from the device.
For MEMS, this will be done with the data from the MEMS device.
For TAU, this will be done with pill counts.
Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment.
|
Week 8 of the 12-week participation period.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anand Mattai, MD, MedicaSafe, Inc.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Distúrbios induzidos quimicamente
- Transtornos Relacionados a Substâncias
- Transtornos Relacionados a Narcóticos
- Distúrbios relacionados a opioides
- Efeitos Fisiológicos das Drogas
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Analgésicos, Opioides
- Narcóticos
- Antagonistas Narcóticos
- Buprenorfina
- Naloxona
- Buprenorfina, combinação de drogas naloxona
Outros números de identificação do estudo
- Pro00023570
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