- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01965405
Smoking Cessation for People Living With HIV/AIDS
Behavioral Smoking Cessation Treatment for People Living With HIV/AIDS
In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke).
- Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone.
- Phase 2a: We hypothesize that non-responders who are assigned to contingency management will be more likely to reduce their smoking throughout treatment and to abstain from smoking at all follow-up points.
- Phase 2b: We hypothesize that responders who are assigned to monitoring and low-magnitude prize contingency management will be more likely to maintain their reduced or abstinent smoking status at all follow-up time-points.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
- Medicamento: Bupropion
- Comportamental: Brief Counseling
- Comportamental: High-magnitude prize contingency management
- Comportamental: Monitored support to quit smoking
- Comportamental: Prize contingency management for abstinence
- Comportamental: No additional treatment
- Comportamental: Low intensity prize contingency management
Descrição detalhada
All research related activities will take place at the Tolan Park Medical Building located at 3901 Chrysler Service Dr, Detroit, 48201.
Participants in Phase 1 will be randomized to one of two brief interventions based on standard of care guidelines (SoC): A) brief counseling and bupropion (SoC); or B) SoC plus brief high-magnitude prize CM (HM-CM). At the end of Phase 1, participants will be classified as responders or non-responders on the basis of smoking reduction/abstinence. All participants will continue to receive bupropion. Non-responders will enter Phase 2a and be randomly assigned to: A) continued counseling and monitoring support to quit smoking (MS); or B) MS plus prize CM for abstinence (MS+CM). Phase 1 responders will be entered into Phase 2b and randomly assigned to: A) no additional treatment (NAT); or B) Continued monitoring and low intensity prize CM (LI-CM). The primary dependent variables will include cotinine and carbon monoxide (CO) levels, and longest duration of abstinence from cigarettes. Seven-day point prevalence will be used to assess outcome at post-treatment, 6-month and 12-month follow-up points.
Participants will be paid $35 for intake and $25 for each follow-up interview, which will occur at post-phase 1, post-phase 2, and 6-months and 12-months after treatment initiation. Some assessments as well as treatment sessions will be recorded to ensure data quality.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Tolan Park Medical Building
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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:
- Age 18 years or older
- Able to read and understand English
- Smoke more than 10 cigarettes/day
- Patient enrolled in the HIV clinic with HIV or AIDS diagnosis
Exclusion Criteria:
- Are actively suicidal or have uncontrolled manic or psychotic symptoms requiring immediate care
- Are in recovery for pathological gambling (PG)
- Have contraindications for bupropion treatment (e.g., presence of epilepsy or other seizure disorder, use of monoamine oxidase inhibitors or other antidepressants, presence of eating disorders or very low weight)
- Are already participating in other smoking cessation interventions.
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 |
---|---|
Experimental: Phase 1: Standard of Care (A)
Brief counseling and bupropion
|
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Outros nomes:
Participants are provided with brief counseling for smoking cessation.
|
Experimental: Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
|
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Outros nomes:
Participants are provided with brief counseling for smoking cessation.
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
|
Experimental: Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
|
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Outros nomes:
Participants are provided with brief counseling for smoking cessation.
Brief supportive sessions and monitoring of smoking cessation efforts.
|
Experimental: Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
|
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Outros nomes:
Brief supportive sessions and monitoring of smoking cessation efforts.
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
|
Experimental: Phase 2b: Responders (A)
Bupropion, no additional treatment.
|
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Outros nomes:
No additional treatment will be given.
|
Experimental: Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
|
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Outros nomes:
Brief supportive sessions and monitoring of smoking cessation efforts.
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Urinary Cotinine
Prazo: Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
|
Urinary cotinine is a metabolite of nicotine, and can be detected in urine.
The presence of cotinine in urine shows recent cigarette smoking.
Cotinine is measured using an instant test that give a score from 0 to 6 on a semi-quantitative scale.
Declining scores show an individual has stopped or significantly reduced their smoking.
|
Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
|
Longest Duration of Continuous Abstinence
Prazo: Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)
|
This is the longest period of consecutive days during treatment where the participant has not smoked.
Longest duration of abstinence is calculated through self-report of smoking abstinence verified by scores on biological measures (negative scores on carbon monoxide or urinary cotinine tests).
|
Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)
|
Seven-Day Point-Prevalence
Prazo: Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
|
At each follow-up assessment, participants will be asked if they had smoked in the preceding seven days.
They will also participate in cotinine and carbon monoxide testing.
Negative scores are given when the participant reports no smoking and all tests are negative.
|
Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
|
Carbon Monoxide Results
Prazo: Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
|
Participants will provide breath carbon monoxide samples at each visit by blowing into a hand-held carbon monoxide reader.
Carbon monoxide is produced when substances (such as cigarettes) are burned.
Thus this test can show if an individual has been smoking recently.
|
Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David Ledgerwood, PhD, Wayne State University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
- 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
- 1R01DA034537-01A1 (Concessão/Contrato do NIH dos EUA)
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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