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- Ensaio Clínico NCT01141855
Smoking Termination Opportunity for inPatients (STOP)
Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.
The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the opportunity that is provided by admission for acute smoking related illness, to assist patients through withdrawal by use of a combination of:
- the new medication Champix with
- best practice counselling
- initiated in an inpatient setting
to achieve:
- sustained smoking abstinence
- reduced hospital bed and health service utilisation
- reduced inpatient smoking and craving prior to discharge
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
A national standard in public hospitals for the management of smoking in patients admitted with smoking related acute illnesses is lacking. Where such patients have continued to smoke up until the time of admission, it can be assumed that "primary" prevention has failed.
Once admitted, there is a vastly under-utilised opportunity, by use of a structured and systematic approach, to intervene with a secondary prevention attempt. This takes advantage of the synergy of:
- the smoker is a "captive audience" and may be receptive to considering lifestyle factors that have lead to the admission, and
- best practice medication and counselling can be initiated prior to discharge. If proven to be cost-effective in our analysis, a systematic roll-out of this secondary prevention initiative would be advocated. ie translation of research into practice.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
-
-
South Australia
-
Adelaide, South Australia, Austrália, 5000
- Royal Adelaide Hospital
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Adelaide, South Australia, Austrália, 5011
- The Queen Elizabeth Hospital
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Adelaide, South Australia, Austrália, 5112
- Lyell McEwin Health Service
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Smoker of at least 10 cigarettes per day on average over the past 12 months
- Inpatient with an anticipation admission of at least one day
- Willingness to quit smoking
- Aged between 20 and 75 years
- A plan of discharge to go home
- Acute hospital admission with cardiovascular, cerebrovascular, peripheral vascular diseases or airways (asthma and/or Chronic Obstructive Pulmonary disease
Exclusion Criteria:
- Subject preference to use an alternative pharmacotherapy for smoking cessation
- Respiratory patient being considered for home oxygen
- Pregnancy
- Breast feeding
- Acute or pre-existing severe psychiatric illnesses
- Past history of psychosis or suicidal ideation
- Renal impairment with creatinine clearance <30ml/min
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Champix plus counselling
varenicline tartrate will be initiated whilst subjects are inpatients with the standard MIMS dosing schedule (including period of titration).
In combination with Quit SA (5A) telephone counselling service
|
Standard MIMS dosage (including period of titration) will be used. 0.5mg daily for 3 days 0.5mg b.d. for 4 days 1mb b.d. for 70 days (full course 3 months)
Outros nomes:
|
Comparador Ativo: counselling alone
5A counselling via Quit SA (quitline) telephone counselling service.
(maximum 8 phone calls per subject within a 3 month period).
|
Quit SA 5A counselling over the phone.
Maximum 8 calls over a 3 month period
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Smoking abstinence
Prazo: one year
|
Continued smoking abstinence is defined as: less than or equal to no more than 5 cigarettes smoked during the period of 2 weeks to 12 months post enrollment.
|
one year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Reduced hospital bed utilisation
Prazo: one year
|
Hospital casemix/DRG data will be collected for the 5 years prior to enrollment and one year post enrollment.
This will be supplemented by SA Department of Health data and PBS/MBS data sets of study completion, to monitor admissions at other hospitals and GP visits.
|
one year
|
7-day point prevalence
Prazo: from 2 weeks to 3 months post enrollment
|
Defined as no cigarettes for the previous 7 days
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from 2 weeks to 3 months post enrollment
|
Reduction in health care costs
Prazo: one year
|
Reduced health care costs with greater economic value will be relative to other health interventions.
Four seperate economic models will be built for vascular diseases: cardiovascular, cerebrovascular and peripheral vascular diseases and airways diseases: asthma and/or chronic obstructive pulmonary disease.
Each model will compare outcomes and costs for varenicline and counselling compared to counselling alone, and will incorporate epidemiological data on natural disease progression of smokers and previous smokers from the four disease profiles split by gender if indicated.
|
one year
|
Inpatient craving levels
Prazo: baseline to end of inpatient stay
|
Craving scales will be used to assess levels during inpatient stay (pre and post intervention delivery)
|
baseline to end of inpatient stay
|
Prevalence of inpatient smoking
Prazo: From baseline to end of inpatient stay
|
Measured by self-report and observation by hospital and study staff prior to discharge.
|
From baseline to end of inpatient stay
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid, The Queen Elizabeth Hospital
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
- 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 colinérgicos
- Agonistas Nicotínicos
- Agonistas colinérgicos
- Vareniclina
Outros números de identificação do estudo
- 2008012
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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