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Bupropion for Smoking Cessation During Pregnancy

5 de junho de 2019 atualizado por: The University of Texas Medical Branch, Galveston
This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy. A total of 150 pregnant smokers will receive medication (75) or placebo (75) for 12 weeks. Compassionate care/continuance of therapy will be available to pregnant subjects. Women who relapse to smoking postpartum will be offered an additional course of medication treatment. All subjects regardless of adherence with 12 week study drug administration period and smoking habits during pregnancy will be followed through the duration of their pregnancy, delivery, and 6-month postpartum period. Subject participation will begin between 13-30 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13) months in length.

Tipo de estudo

Intervencional

Inscrição (Real)

65

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Texas
      • Galveston, Texas, Estados Unidos, 77555
        • University of Texas Medical Branch at Galveston

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days
  • 13-30 weeks gestation
  • ≥18 years of age
  • able to speak English or Spanish
  • intent to carry pregnancy to term
  • stable residence

Exclusion Criteria:

  • current illicit drug or alcohol abuse or dependence
  • twins or other multiple gestation
  • treatment for psychiatric disorder within the last 6 months
  • unstable medical problems (eg, hypertension (BP>140/90), preeclampsia, threatened abortion, hyperemesis gravidarum)
  • known congenital abnormality
  • seizure disorder
  • use of psychotropic medication
  • use of medication known to lower the seizure threshold
  • anorexia/bulimia
  • a personal history of closed head trauma with > 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion
  • use of any other smoking cessation treatment in the past 30 days
  • current enrollment in methadone treatment program
  • prior pregnancy with preeclampsia diagnosis
  • chronic hypertension (past history or current diagnosis)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Bupropion SR + cessation counseling

Bupropion SR and smoking cessation counseling Subjects received Bupropion SR 150 mg tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (bupropion SR 150 mg orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose Bupropion SR 150 mg tablet orally BID for a total medication treatment of 12 full weeks.

Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.
Medicamento: Bupropion SR
Bupropion SR 150 mg tablet
Outros nomes:
  • Zyban
  • buproban
Comportamental: Smoking Cessation Counseling
35-min counseling by trained research nurse
Outros nomes:
  • Aconselhamento comportamental
Comparador de Placebo: Placebo + cessation counseling

Placebo and smoking cessation counseling Subjects received matching Bupropion SR placebo tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose matching Bupropion SR placebo tablet orally BID for a total medication treatment of 12 full weeks of therapy.

Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.
Comportamental: Smoking Cessation Counseling
35-min counseling by trained research nurse
Outros nomes:
  • Aconselhamento comportamental
Medicamento: Placebo
Matching Bupropion SR placebo tablet
Outros nomes:
  • Ao controle

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment
Prazo: During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)
Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.
During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date
Prazo: Quit date, visit 2 (one week after starting the 12-week course of therapy)
Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.
Quit date, visit 2 (one week after starting the 12-week course of therapy)
Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6)
Prazo: Visit 6 (end of 12 weeks of medication therapy)
The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air < 4 ppm, and concentrations of cotinine in urine < 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.
Visit 6 (end of 12 weeks of medication therapy)
Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7)
Prazo: End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation
The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air < 4 ppm, and concentrations of cotinine in urine < 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.
End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The University of Texas Medical Branch, Galveston

Colaboradores

National Institute on Drug Abuse (NIDA)
UConn Health

Investigadores

  • Investigador principal: Gary DV Hankins, MD, University of Texas Medical Branch at Galveston
  • Investigador principal: Tatiana Nanovskaya, PhD, University of Texas Medical Branch at Galveston
  • Investigador principal: Cheryl Onken, MD, MPH, UConn Health
  • Investigador principal: Mahmoud Ahmed, PhD, University of Texas Medical Branch at Galveston
  • Investigador principal: Shannon Clark, MD, University of Texas Medical Branch at Galveston

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2011

Conclusão Primária (Real)

1 de dezembro de 2016

Conclusão do estudo (Real)

1 de dezembro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de julho de 2011

Primeira postagem (Estimativa)

8 de julho de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de junho de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de junho de 2019

Última verificação

1 de fevereiro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 10-217
  • R01DA030998 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

No plan

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