Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98104
- Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)
-
-
Wisconsin
-
Madison, Wisconsin, Estados Unidos, 53711
- University of Wisconsin Center for Tobacco Research and Intervention
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
The only people eligible for this study are Wisconsin residents who contact the Wisconsin Tobacco Quit Line for smoking cessation services.
Inclusion Criteria:
- Callers will be eligible to participate in the study if they are English speaking; are 18 years of age or older; smoke a minimum of 10 cigarettes per day; are interested in quitting and are willing to set a quit date; willing and able to use nicotine patch and nicotine gum; agree to receive four follow-up counseling calls from Free & Clear (the quitline vendor for the State of Wisconsin); provide verbal informed consent; and provide contact information and agree to take four study follow-up calls from staff at the University of Wisconsin Center for Tobacco Research and Intervention.
Exclusion Criteria:
- Callers will be excluded if they are under the age of 18; are pregnant or breastfeeding; exclusively use other forms of tobacco (e.g., smokeless tobacco); are unwilling or unable to use study NRT medications; are currently using a cessation medication (NRT, bupropion, varenicline); or have medical exclusions as per FDA-approved product labeling.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 2 Weeks of Nicotine Patch Only, No CMAC
Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day |
|
Comparador Ativo: 2 Weeks of Nicotine Patch Only plus CMAC
Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls.
The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
Outros nomes:
|
|
Comparador Ativo: 2 Wks Nicotine Patch+Nic Gum, No CMAC
Participants in this randomization arm received 2 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks 2 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
Outros nomes:
|
|
Comparador Ativo: 2 Wks Nicotine Patch+Nic Gum plus CMAC
Participants in this randomization arm received 2 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks 2 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls.
The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
Outros nomes:
If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
Outros nomes:
|
|
Comparador Ativo: 6 Weeks of Nicotine Patch Only, No CMAC
Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day |
|
Comparador Ativo: 6 Weeks of Nicotine Patch Only plus CMAC
Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls.
The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
Outros nomes:
|
|
Comparador Ativo: 6 Wks Nicotine Patch+Nic Gum, No CMAC
Participants in this randomization arm received 6 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks 6 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
Outros nomes:
|
|
Comparador Ativo: 6 Wks Nicotine Patch+Nic Gum plus CMAC
Participants in this randomization arm received 6 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks 6 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls.
The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
Outros nomes:
If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
7-Day Point Prevalence Abstinence From Smoking by Intervention
Prazo: 26 weeks after the target quit smoking date
|
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
|
26 weeks after the target quit smoking date
|
|
7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group
Prazo: 26 weeks after the target quit smoking date
|
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
|
26 weeks after the target quit smoking date
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
Prazo: 26 weeks after the target quit smoking date
|
For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER.
Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only).
Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded.
ICER ratio is a measure of the added cost per added quit for two treatments.
ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384)
= $357.
|
26 weeks after the target quit smoking date
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stevens S Smith, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
- Diretor de estudo: Paula A Keller, MPH, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
Outros números de identificação do estudo
- H2009-0074
- 1RC1CA144382-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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 .