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Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers
Visão geral do estudo
Status
Condições
Descrição detalhada
Cigarette smoking is the most lethal substance use disorder in the United States in terms of morbidity and mortality. Veterans who are homeless, along with those who have mental health or substance abuse problems, are at the highest risk for nicotine dependence. Prevalence estimates for smoking among homeless Veterans are 80%. Thus, homeless Veterans are at tremendous risk for smoking related morbidity and mortality. This information suggests that smoking needs to be targeted specifically among this high risk population of smokers.
The addition of contingency management (CM) to existing evidence-based tele-health smoking cessation interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation treatment. CM is a behavioral therapy that provides positive reinforcers to individuals misusing substances contingent upon objective evidence of abstinence from substance use. Because CM requires verification of abstinence multiple times daily with a clinic-based carbon monoxide (CO) monitor, it has largely been relegated to inpatient and day treatment programs. The application of emerging smart phone technology, however, can overcome this barrier, and may be particularly well suited to homeless Veterans. The innovative smart phone application has made the use of CM for outpatient smoking cessation portable and feasible. The goal of this comparative effectiveness trial is to evaluate the effectiveness of a combined tele-health and mobile CM intervention that the investigators are calling Abstinence Reinforcement Therapy (ART). The investigators propose to screen 165 and randomize 126 homeless Veteran smokers to either:
ABSTINENCE REINFORCEMENT THERAPY (ART), a tele-health intervention that combines guideline-based cognitive-behavioral telephone (CBT) counseling, a tele-medicine clinic for access to smoking cessation aids including choice of pharmacotherapy, and intensive behavioral therapy through mCM.
VA SPECIALTY SMOKING CESSATION TREATMENT control, which includes all the elements associated with enrollment in a VA specialty smoking cessation clinic including group counseling, individual telephone counseling, self-help materials, and smoking cessation aids including choice of pharmacotherapy.
Specific aims are to:
AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence at post-treatment, and 3-month and 6-month post-randomization follow-ups.
AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted life years (QALY).
AIM 3: Evaluate potential treatment mediators including self-efficacy-related mechanisms.
Supplementary AIM: To evaluate the impact of psychiatric (i.e., PTSD, depression and alcohol abuse) symptoms on treatment outcome across the two conditions.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Durham VA Medical Center, Durham, NC
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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:
- Veteran
- Homeless
- Enrolled in Durham VA Medical Center for medical care
- Current smoker (at least 10 cigarettes per day)
- Willing to quit smoking in the next 30 days
Exclusion Criteria:
- Active substance dependence other than nicotine
- Uncontrolled psychotic symptoms
- Severely impaired hearing or speech (must be able to respond to telephone calls)
- Lack of interest in receiving telephone care
- Pregnancy
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 |
|---|---|
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Experimental: ART
Participants assigned to this treatment arm will receive a tele-health intervention that combines guideline-based cognitive-behavioral counseling for smoking cessation, a tele-medicine clinic for access to smoking cessation aids, and an intensive behavioral therapy for smoking cessation called mobile contingency management.
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Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date.
Nicotine patches may be provided to control group participants as part of usual care.
Outros nomes:
Mobile contingency management (mCM) is a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking.
In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor.
Participants are trained to upload videos of themselves taking CO readings.
Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward.
Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date.
Nicotine gum or lozenges may be provided to control group participants as part of usual care.
Outros nomes:
Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date.
Bupropion may also be prescribed to control group participants as part of usual care.
Outros nomes:
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Comparador Ativo: Control Group
Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
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Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date.
Nicotine patches may be provided to control group participants as part of usual care.
Outros nomes:
Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date.
Nicotine gum or lozenges may be provided to control group participants as part of usual care.
Outros nomes:
Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date.
Bupropion may also be prescribed to control group participants as part of usual care.
Outros nomes:
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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 Self-reported and Bioverified Abstinent From Smoking
Prazo: 6 months
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Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intervention Delivery Costs
Prazo: 6 months
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Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean C Beckham, PhD, Durham VA Medical Center, Durham, NC
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
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
- Transtorno do Uso de Tabaco
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Agentes colinérgicos
- Inibidores Enzimáticos
- Drogas Psicotrópicas
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Antidepressivos
- Agentes de Dopamina
- Inibidores da enzima citocromo P-450
- Estimulantes ganglionares
- Agonistas Nicotínicos
- Agonistas colinérgicos
- Agentes antidepressivos de segunda geração
- Inibidores do citocromo P-450 CYP2D6
- Inibidores de Captação de Dopamina
- Nicotina
- Bupropiona
Outros números de identificação do estudo
- D1301-R
- 1828 (Outro identificador: VA IRB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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