Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness (New HART)
15 de julho de 2026 atualizado por: VA Office of Research and Development
Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans.
Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people.
The purpose of this study study is to evaluate the effectiveness of an intervention to help Veterans experiencing homelessness stop smoking.
The intervention, called Abstinence Reinforcement Therapy + (ART+), includes telehealth-based counseling, smoking cessation aids, and mobile contingency management (mCM).
mCM is an intervention in which participants are paid for smoking abstinence.
120 Veterans who smoke cigarettes and are experiencing homelessness will be randomly assigned to receive either ART+ or usual smoking cessation care.
The primary outcome to be evaluated is the rate at which Veterans assigned to the ART+ condition report smoking abstinence and have their abstinence verified using salivary testing.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
Significance to VA: Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans.
Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people.
While there are numerous challenges to smoking cessation among Veterans experiencing homelessness, four in five homeless smokers report interest in quitting.
Innovation and Impact: The investigators recently developed and evaluated the effectiveness of a multi-component intervention called Abstinence Reinforcement Therapy (ART), which combined five sessions of telehealth-based cognitive-behavioral therapy, provision of smoking cessation aids, and four weeks of mobile contingency management (mCM).
The investigators have added an additional CM period of eight weeks and opportunities for booster calls and repeated quit attempts, resulting in an intervention called ART+ to improve outcomes over time.
The innovative use of web-based platform technology in the current proposal will remove numerous barriers that often prevent smokers experiencing homelessness from accessing high-quality, evidence-based care.
There is tremendous inequity in smoking-related outcomes for VEH.
The innovative use of mobile health technology in the current proposal will remove numerous barriers that often prevent Veterans who smoke and experience homelessness from accessing high- quality, evidence-based care.
Specific Aims: Aim 1: Evaluate the comparative effectiveness of ART+ on bio-verified abstinence outcomes at three-, six-and 12-month follow-ups.
The primary endpoint will be bioverified prolonged abstinence at the six-month follow-up.
Aim 2: Assess the relative cost-effectiveness of ART+ to VA standard care smoking cessation on quality adjusted life years (QALY).
Aim 3: Qualitatively evaluate implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs.
Methodology: 120 Veterans experiencing homelessness who smoke cigarettes will be randomly assigned to ART+ or to VA standard smoking cessation care.
Self-reported and bioverified abstinence at six months are the primary outcomes.
Cost-effectiveness analyses will be performed using QALY as the effectiveness measure.
Rapid qualitative analytic methods will be used to evaluate implementation determinants of ART+ following enrollment of all study participants.
Participants for the qualitative analysis will include clinicians and clinical support staff who provide care to Veterans experiencing homelessness, designated VA operations partners, and VA Tobacco Treatment Specialists.
Purposive sampling will be used to identify potential participants and a structured interview guide based upon domains from the Consolidated Framework for Implementation Research (CFIR) will be administered.
The investigators will use rapid qualitative analysis to answer the key qualitative research question: "What determinants will impact implementation of ART+?"
The benefit of decreasing tobacco use (Aim 1) among VEH who smoke is tremendous as it will prevent significant morbidity and mortality.
Moreover, if ART+ is shown to be cost effective (Aim 2) and implementation determinants are identified (Aim 3), the use of mobile phones as a platform to provide behavioral incentives has the potential to transform the delivery of smoking cessation care.
Path to Translation/Implementation: Cost-effectiveness analysis (Aim 2) will help guide implementation decisions.
Qualitative evaluation of the implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs (Aim 3) will provide important information on effective implementation of ART+.
Tipo de estudo
Intervencional
Inscrição (Estimado)
120
Estágio
- Não aplicável
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.
Contato de estudo
- Nome: Angela C Kirby, MS
- Número de telefone: 7456 (919) 286-0411
- E-mail: angela.kirby@va.gov
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705-3875
- Durham VA Medical Center, Durham, NC
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Contato:
- Angela C Kirby, MS
- Número de telefone: 7456 919-286-0411
- E-mail: angela.kirby@va.gov
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Investigador principal:
- Jean C Beckham, PhD
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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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Are homeless
- Smoke at least 5 cigarettes daily with CO indicating current smoking at time of screening assessment
- Are willing to try to quit smoking in next 30 days
Exclusion Criteria:
- Have uncontrolled psychotic symptoms
- Have active substance dependence other than nicotine (participants in partial remission with at least one month sobriety will be included)
- Have severely impaired hearing or speech
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
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Abstinence Reinforcement Therapy +
Abstinence Reinforcement Therapy +, or ART+, includes five sessions and several booster sessions of cognitive-behavioral therapy for smoking cessation, two forms of nicotine replacement therapy plus bupropion or varenicline, and mobile contingency management for smoking cessation.
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Five core sessions of CBT plus up to four monthly booster sessions designed to help Veterans prepare to quit smoking, make a quit attempt, and prevent relapse to smoking.
Outros nomes:
NRT is a group of over-the-counter medications designed to help users quit smoking.
Standard of care often involves use of nicotine patch plus one rescue method (either gum or lozenge).
Outros nomes:
Bupropion is an FDA-approved prescription smoking cessation aid.
Participants will be prescribed 150-300 mg.
Outros nomes:
Varenicline is an FDA-approved prescription smoking cessation aid.
Participants will be 0.5 to 2 mg.
Outros nomes:
Smoking abstinence will be intermittently reinforced.
For each carbon monoxide (CO) reading that a participant provides that suggest smoking abstinence, the participant will earn spins on a virtual prize wheel that has financial prizes.
Outros nomes:
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Comparador Ativo: Standard Care Condition
Standard Care Condition will involve referral to local VA clinic-based smoking cessation care.
This care often includes pharmacotherapy, counseling options, and/or use of a telephone-based, texting-based or app-based smoking cessation program.
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NRT is a group of over-the-counter medications designed to help users quit smoking.
Standard of care often involves use of nicotine patch plus one rescue method (either gum or lozenge).
Outros nomes:
Bupropion is an FDA-approved prescription smoking cessation aid.
Participants will be prescribed 150-300 mg.
Outros nomes:
Varenicline is an FDA-approved prescription smoking cessation aid.
Participants will be 0.5 to 2 mg.
Outros nomes:
Participants assigned to the usual care condition may participate in group counseling for smoking cessation, which can also include use of phone-based smoking cessation resources such as a telephone quit line, a texting program, and a smoking cessation app.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants whose self-report of prolonged smoking abstinence is bioverified
Prazo: 6-month follow-up, about six months after baseline
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Prolonged abstinence is defined as 30 days abstinent.
For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL)
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6-month follow-up, about six months after baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants whose self-report of prolonged smoking abstinence is bioverified
Prazo: 3-month follow-up, about three months after baseline
|
Prolonged abstinence is defined as 30 days abstinent.
For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL)
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3-month follow-up, about three months after baseline
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Number of participants whose self-report of prolonged smoking abstinence is bioverified
Prazo: 12-month follow-up, about twelve months after baseline
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Prolonged abstinence is defined as 30 days abstinent.
For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL
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12-month follow-up, about twelve months after baseline
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Number of participants who self-report 7-day point prevalence abstinence
Prazo: 3-month follow-up, about three months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 7 days
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3-month follow-up, about three months after baseline
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Number of participants who self-report 7-day point prevalence abstinence
Prazo: 6-month follow-up, about six months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 7 days
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6-month follow-up, about six months after baseline
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Number of participants who self-report 7-day point prevalence abstinence
Prazo: 12-month follow-up, about twelve months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 7 days
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12-month follow-up, about twelve months after baseline
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Number of participants who self-report 30-day point prevalence abstinence
Prazo: 3-month follow-up, about three months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 30 days
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3-month follow-up, about three months after baseline
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Number of participants who self-report 30-day point prevalence abstinence
Prazo: 6-month follow-up, about six months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 30 days
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6-month follow-up, about six months after baseline
|
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Number of participants who self-report 30-day point prevalence abstinence
Prazo: 12-month follow-up, about twelve months after baseline
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30-day point prevalence abstinence is defined as no smoking in the prior 30 days
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12-month follow-up, about twelve months after baseline
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Number of participants who self-report early continuous abstinence
Prazo: 3-month follow-up, about three months after baseline
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Early continuous abstinence will be defined as reporting two weeks of continuous abstinence during the first four weeks after the quit day
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3-month follow-up, about three months after baseline
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Incremental Cost-Effectiveness Ratio
Prazo: 12 months post quit, about 12 months after baseline
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Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator.
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12 months post quit, about 12 months after baseline
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Percentage of carbon monoxide reading completion by participants in ART+ intervention group
Prazo: 3-month follow-up, about three months after baseline
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Patient intervention utilization will be measured by the percentage of prompted carbon monoxide readings that participants in the ART+ condition complete during the treatment period.
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3-month follow-up, about three months after baseline
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Number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in ART+ intervention group
Prazo: 3-month follow-up, about three months after baseline
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Patient intervention utilization will be measured by the number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in the ART+ condition during the treatment period
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3-month follow-up, about three months after baseline
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Number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period
Prazo: 3-month follow-up, about three months after baseline
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Patient intervention utilization will be measured by the number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period.
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3-month follow-up, about three months after baseline
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jean C Beckham, PhD, Durham VA Medical Center, Durham, NC
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 (Estimado)
1 de março de 2027
Conclusão Primária (Estimado)
1 de março de 2030
Conclusão do estudo (Estimado)
1 de setembro de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
15 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de julho de 2026
Primeira postagem (Real)
20 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Transtornos Relacionados a Substâncias
- Distúrbios induzidos quimicamente
- Comportamento
- Transtorno do Uso de Tabaco
- Fumar
- Produtos químicos orgânicos
- Piridinas
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Terapêutica
- Terapia medicamentosa
- Comida
- Dieta, comida e nutrição
- Fenômenos fisiológicos
- Comida e bebidas
- Carboidratos
- Alcalóides
- Terapia comportamental
- Psicoterapia
- Disciplinas e atividades comportamentais
- Polímeros
- Substâncias macromoleculares
- Polissacarídeos
- Benzazepínicos
- Cetonas
- Biopolímeros
- Quinoxalinas
- Gomas de plantas
- Doce
- Alcalóides solanáceos
- Chiclete de mascar
- Propiofenonas
- Vareniclina
- Nicotina
- Bupropiona
- Terapia cognitivo -comportamental
- Dispositivos de cessação de uso do tabaco
- Terapia de reposição de nicotina
- Goma de mastigação de nicotina
Outros números de identificação do estudo
- HSR2-003-25M
- 1924743 (Outro identificador: Durham VA Medical Center IRB)
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
produto fabricado e exportado dos EUA
Não
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