- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00261170
Bupropion for Hospital-Based Smoking Cessation
Visão geral do estudo
Descrição detalhada
Two hundred and seventy patients will be enrolled;approximately 135 will be randomized to each study arm over the course of 24 months. Patients will be considered smokers if they have used tobacco products during the week prior to admission and if they have smoked> or = 5 cigarettes /day during the previous year.Smokers will be identified by review of admissions and given a flyer to invite them to join the study. Interested smokers will be screened and asked to fill out a Beck Depression Inventory. Patients with very high Beck Depression Inventory Scores, i.e. > or = 30, will not be enrolled because such individuals may require other treatment. Each patient's physician will be contacted to verify his/her eligibility for the study. Once eligibility has been ascertained, a research associate will visit the patient to obtain informed consent and to enroll them in the study. Study questionnaires and a Fagerstrom test for Nicotine Dependence will be completed and reviewed by a research associate for completeness at the time of enrollment. The associate will put in the prescription for the study drug and request the order for dispensing of the drug. The research pharmacist will randomize the patient to Study Arm 1 or Study Arm 2.
Subjects randomized to Study Arm 1 will receive a standard 7-week course of sustained release bupropion (150 mg/day for the first 3 days, then 150mg BID), a self-help booklet, counseling on smoking cessation strategies, and follow-up phone counseling during the first 3 months after randomization. Study Arm 2 participants will receive the same intervention as Study Arm 1, but will receive placebo instead of active bupropion therapy. Both study groups will complete study questionnaires regarding their medical and smoking history and will be followed one week after their hospital discharge to record their blood pressure and to monitor possible side effects.
Since quit rates tend to decline over time, relapse prevention approaches will be included in both study arms. Marlatt's theory of relapse, an extension of Bandura's social learning model, will be used to augment the quitter's perception of self-efficacy. Participants will be trained to resist and cope with the temptations and stresses likely to be encountered after discharge from the hospital. Behavioral self-management techniques to counter known relapse-triggers such as stress, the presence of other smokers, alcohol use and depression will be discussed during follow-up counseling calls.
We will measure saliva cotinine in all participants who give a history of smoking abstinence at the end of treatment and at 6 months. Cotinine levels of > or + 15 ng/mL will be considered evidence of current tobacco use. Participants who are self-reported quitters, but have failed to provide a saliva sample will be considered as smokers unless verification from a spouse or significant other can be obtained. Participants who have died will be analyzed as smokers or quitters based on prior self-report, information in medical records, or interviews with next-of-kin. Others will be censored (i.e. excluded from the analysis). All cotinine samples will be assayed at the University of California, San Francisco,laboratory of Dr. Neal Benowitz.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
-
-
California
-
San Francisco, California, Estados Unidos, 94121
- Veterans Affairs Medical Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- currently smoking - use of tobacco products during the week prior to hospital admission and having smoked at least 5 cigarettes /day during the past year
- eligibility to receive medical care in a VA hospital
- hospitalization for at least 48 hours to provide sufficient time to identify, screen, enroll and counsel participants
- willingness to participate and give informed consent
Exclusion Criteria:
- hospitalization for acute CHD syndromes
- contraindications to the use of bupropion
- family history of seizure disorder, history of severe head trauma, predisposition to seizures
- unstable psychiatric disorder
- pregnancy, lactation
- current alcohol (defined as greater than 3 drinks/day) or drug abuse (defined as current/within last 3 months use of narcotics, heroin, cocaine, amphetamines)
- current untreated depression (BDI score > or = 30)
- terminal illness
- inability to be contacted by phone
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 1
bupropion and behavioral counseling
|
150 mg daily for the first 3 days, then 150 mg twice daily for 7 weeks
Outros nomes:
|
Comparador de Placebo: 2
placebo medication
|
1 pill daily for the first 3 days, then one pill twice daily for 7 weeks
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Smoking status at 6 months after enrollment
Prazo: 6 months
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
smoking status at end of treatment
Prazo: 7 weeks
|
7 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joel A Simon, MD, MPH, University of California, San Francisco
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
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Drogas Psicotrópicas
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Antidepressivos
- Agentes de Dopamina
- Inibidores da enzima citocromo P-450
- Agentes antidepressivos de segunda geração
- Inibidores do citocromo P-450 CYP2D6
- Inibidores de Captação de Dopamina
- Bupropiona
Outros números de identificação do estudo
- 12RT-0148
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 .
Ensaios clínicos em bupropion
-
Orexigen Therapeutics, IncConcluídoObesidade | Excesso de pesoEstados Unidos
-
Orexigen Therapeutics, IncConcluídoObesidadeEstados Unidos
-
Alembic Pharmaceuticals Ltd.Concluído
-
Thomas Jefferson UniversityAtivo, não recrutandoCarcinoma Espinocelular de Cabeça e Pescoço | Carcinoma de Pulmão de Células Não PequenasEstados Unidos
-
Orexigen Therapeutics, IncConcluídoUm estudo de segurança e eficácia de naltrexona SR/Bupropion SR em indivíduos com sobrepeso e obesosObesidade | Excesso de pesoEstados Unidos
-
Orexigen Therapeutics, IncConcluídoObesidade | Excesso de peso | Dependência de nicotinaEstados Unidos
-
New York State Psychiatric InstituteConcluídoDepressão Maior | Distimia | Depressão SOEEstados Unidos
-
University of Wisconsin, MadisonNational Institutes of Health (NIH)Concluído
-
Orexigen Therapeutics, IncConcluídoObesidade | Diabetes Mellitus, Tipo 2 | Excesso de pesoEstados Unidos
-
Orexigen Therapeutics, IncConcluídoDepressãoEstados Unidos