- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00770237
Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia
In this study, we will compare cue-reactivity in smokers with and without schizophrenia and the influence of smoking cues on responding for cigarette puffs under a PR schedule of reinforcement. Given the high prevalence of smoking among individuals with schizophrenia, understanding some of the environmental factors that serve to maintain nicotine dependence is a critical step in improving smoking cessation treatment outcomes. Establishing and validating a laboratory model of cue-elicited responsivity and cigarette self- administration will allow the investigation of the efficacy of anti-craving medications in people with schizophrenia.
Specific Aims 1) To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia. 2) To compare the effects of smoking versus neutral cues on the reinforcing efficacy of tobacco cigarettes in smokers with schizophrenia and smokers without schizophrenia.
Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).
The ratio of 3-HC/cotinine is a phenotypic biomarker of the rate of nicotine metabolism, which has been shown to be associated with level of nicotine dependence, various smoking behaviors, and treatment outcome (Ho & Tyndale, 2007). We will correlate the primary measures with the 3-HC/cotinine ratio to explore possible relationships for future study.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Maryland
-
Catonsville, Maryland, Estados Unidos, 21228
- Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria for Schizophrenia Patients
- 18-64 year old males and females
- Smoking at least 10 cigarettes per day for at least 1 year
- Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
- Current DSM-IV diagnosis of schizophrenia and stable medication regimen (see above)
- Medically healthy as determined by screening criteria
Inclusion Criteria for Healthy Volunteers
- 18-64 year old males and females
- Smoking at least 10 cigarettes per day for at least 1 year
- Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
- Medically and psychologically healthy as determined by screening criteria
Exclusion Criteria for Schizophrenia Patients
- Current interest in reducing or quitting tobacco use
- Treatment for tobacco dependence in the past 3 months
- Use of nicotine replacement products, bupropion, or varenicline in the past 3 months
- Consumption of more than 15 alcoholic drinks per week during the past month
- Use of any illicit drug more than twice per week during the past month
- Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, first-generation antipsychotics, and mood stabilizers)
- Under the influence of a drug or alcohol at experimental sessions
- Pregnant, nursing, or become pregnant during the study
Exclusion Criteria for Healthy Volunteers
- Current interest in reducing or quitting tobacco use
- Treatment for tobacco dependence in the past 3 months
- Use of nicotine replacement products, bupropion, or varenicline in the past 3 months
- Consumption of more than 15 alcoholic drinks per week during the past month
- Use of any illicit drug more than twice per week during the past month
- Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, antipsychotics, and mood stabilizers)
- Under the influence of a drug or alcohol at experimental sessions
- Pregnant, nursing, or become pregnant during the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Cues
Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity.
During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken.
Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).
|
In the smoking cue condition, a pack of the participants preferred brand of cigarettes, a lighter, and an ashtray will be under the tray cover.
In the neutral cue condition, a pack of unsharpened pencils, a pencil sharpener, and a small notepad will be under the cover.
When instructed, the participant will lift the cover on the tray.
In the smoking cue condition, participants will take one cigarette out of the pack, light it without puffing, hold it for 1 minute, extinguish the cigarette, and replace the cover on the tray.
In the neutral cue condition, participants will take one pencil out of the pack, sharpen it, hold it for 1 minute as if to write on the notepad, and then replace the cover.
Participants will complete the VAS during cue exposure and the TCQ-SF, VAS, and mood form immediately and 15 minutes after cue presentation; physiological measures will be recorded continuously.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia.
Prazo: 7-10 Days
|
7-10 Days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stephen J Heishman, Ph.D., National Institute on Drug Abuse (NIDA)
- Investigador principal: Deanna L Kelly, Pharm.D, BCPP, University of Maryland, College Park
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
Outros números de identificação do estudo
- HP-00042356
- NIDA 430
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 Smoking Cues
-
Cue BiopharmaRecrutamentoCâncer de intestino | Câncer colorretal | Câncer de pâncreas | Cancro do ovárioEstados Unidos
-
Wayne State UniversityNational Institute on Drug Abuse (NIDA)Concluído
-
University of TriesteConcluídoDoença de Parkinson
-
Ohio State UniversityRutgers UniversityRecrutamento
-
Washington University School of MedicineCue BiopharmaRecrutamento
-
Brigham and Women's HospitalNational Institute on Aging (NIA)ConcluídoDoenças Reumáticas | Lúpus Eritematoso Sistêmico | Adesão, Medicação | GotaEstados Unidos
-
Loma Linda UniversityConcluídoEfeito da sinalização integrada nas transferências funcionais em sobreviventes de AVC crônico (EOIC)Hemiplegia e/ou hemiparesia após AVCEstados Unidos
-
Scripps Translational Science InstituteCue HealthRecrutamentoInfecções por HIV | Linfoma | Leucemia | Câncer | Mieloma múltiplo | Imunossupressão | Imunodeficiência | Transplante | Doença do Enxerto Contra o Hospedeiro | Imunodeficiência Relacionada à IdadeEstados Unidos
-
Becton, Dickinson and CompanyConcluídoComplicação Relacionada ao CateterEstados Unidos
-
Cue BiopharmaMerck Sharp & Dohme LLCAtivo, não recrutandoCâncer de Cabeça e Pescoço | Carcinoma Relacionado ao HPV | Carcinoma de Células Escamosas de Orofaringe Positivo para HPVEstados Unidos