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Utilizing Helpline for Opioid Dependence Treatment

22 de maio de 2026 atualizado por: Nassima Ait-Daoud Tiouririne, University of Virginia
The investigator propose to develop an opioid telephone helpline, where trained counselors and educators provide referral, educational and targeted interventions and support to individuals interested in addressing their addiction or needing help with managing their pain. The proposed application builds on "tobacco quit line" efforts, a nationally-adopted telephone-based service, providing education materials, access to cessation medication and counseling against tobacco use. Similar to tobacco quit line; the proposed telephone based services will remove barriers to treatment as they help individuals at the exact time of need. The helpline will also educate individuals with new onset pain about pain expectations, relaxation techniques, use of pharmacology and psychotherapy for treatment in addition to providing support for coping and reducing dependency on prescription opioids. It will be a low cost, easily accessible and utilizable technology to augment the clinical outcome of medication assisted treatment of opioid use disorder and pain management.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The proposed specific aims are to:

  1. Test if the helpline is a resourceful tool for patients with opioid use disorder looking for referrals and support to access treatment. The opioid helpline will provide individuals with opioid use disorder seeking treatment, direct access to a live person who can answer questions regarding referrals and various treatment programs. The helpline will also follow-up on treatment compliance and offer support and motivational techniques for these individuals to stay engaged in treatment
  2. Test if the helpline is a resourceful tool for patients with new onset of pain or chronic pain being prescribed opioids. The opioid helpline will provide these individuals the necessary educational materials on managing pain safely while avoiding misuse. It will offer free imagery guided meditation and other non-pharmacological tools to help with pain management.
  3. Test if providers find the opioid helpline helpful and resourceful for their practice and are willing to refer patients to the helpline.

Tipo de estudo

Observacional

Inscrição (Real)

31

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • UVA Center for Leading Edge Addiction Research

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

We plan to pilot this model in a small rural area with low accessibility to specialized treatment. We will specifically target the area of county of Wise as it is an area with one of the highest rate of opioid addiction and overdose related deaths in the state.

UVA hospital: we plan to pilot this model at UVA hospital because it is a health care system offering care to a diverse population from urban and rural areas.

The providers will be educated regarding the goals and objectives of the helpline: Any specialty physicians, nurses including dentists that prescribes opioids within Virginia They will be asked to have flyers about the helpline in their office and refer patients who are prescribed opioids to get more support from the helpline.

Descrição

Inclusion Criteria:

Participant Criteria:

  1. Age greater than or equal to 18 years.
  2. A formal diagnosis of Opioid Use Disorder (OUD) by a health care provider or
  3. If no formal diagnosis of OUD, having a self-reported concern with opioid use or addiction.
  4. An individual seeking to reduce opioid use.
  5. An individual concerned about opioids prescribed for management of new-onset pain or chronic pain.

Provider Criteria:

  1. University of Virginia: Providers of any specialties within VA including dentists that prescribes opioids.
  2. County of Wise: Providers of any specialties including dentists that prescribes opioids.

Exclusion Criteria:

Participant Criteria:

  1. Individuals under 18 years of age.
  2. Individuals seeking treatment for non-opioid substance use disorders
  3. Individuals who have no pain issues
  4. Individuals located outside of Virginia.

Provider Criteria:

Providers outside the designated regions.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Patients/Providers
Of the1,000 participants: (1) 900 will enroll as participants who use the helpline resources via verbal consent and (2) 100 will enroll as providers via online consent prior to survey data collection.
Comportamental: Helpline
This helpline will aim to provide patients with new diagnosis of pain who are prescribed opioids, access to education, support and free behavioral technique to help manage their pain such as mindfulness exercises. For those with opioid use disorder, the helpline will offer support in the form of education about the disorder, opioid withdrawal symptoms, risks of overdoses, and a variety of services such as help reach appropriate care with MAT licensed providers, information on FDA-approved MAT and naloxone, and, in some cases, behavioral intervention to keep patients engaged in treatment. The opioid helpline will provide a central resource for direct services and a portal for community services. It will also serve as a referral resource for health-care professionals.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Participant Opioid Helpline Survey
Prazo: up to a year
Primary outcomes measure the rating of the Helpline by the patients. They will be sent surveys that will ask the patients to rate the services they receive on a scale of 1 to 10, with 1 meaning they are very dissatisfied and 10 meaning they are very satisfied.
up to a year
Provider Opioid Helpline Survey
Prazo: up to a year
Primary outcomes measure the rating of the Helpline by the providers. They will be sent surveys that will ask the providers to rate the services they receive on a scale of 1 to 10, with 1 meaning they are very dissatisfied and 10 meaning they are very satisfied.
up to a year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of participants reached versus called.
Prazo: up to a year
Total number of contacts to the Helpline compared to the number that prescreened and the number consented.
up to a year
Number of participants who continued to access the services of Helpline
Prazo: up to a year
The investigator will measure the number of participants who continued to access the services of Helpline up to a year.
up to a year
New General Self-Efficacy Measure
Prazo: up to a year
By using this survey, the investigator will determine the participant's ability to handle the situation that prompted the participant to call the Helpline originally.
up to a year
Opioid Helpline Study Screen Form
Prazo: up to a year
This will be use to collect demographic information for individuals who self-identify as needing help or resources from the Helpline.
up to a year
Referral follow-ups
Prazo: up to a year
Assess which referrals were followed up on by the participants.
up to a year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Virginia

Investigadores

  • Investigador principal: Nassima Ait-Daoud Tiouririne, M.D., University of Virginia

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de junho de 2019

Conclusão Primária (Real)

4 de maio de 2021

Conclusão do estudo (Real)

4 de maio de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

27 de março de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de maio de 2019

Primeira postagem (Real)

31 de maio de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 21376

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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