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Bupropion for Smoking Cessation During Pregnancy

5. června 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

65

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Texas
      • Galveston, Texas, Spojené státy, 77555
        • University of Texas Medical Branch at Galveston

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Lék: Bupropion SR
Bupropion SR 150 mg tablet
Ostatní jména:
  • Zyban
  • buproban
Behaviorální: Smoking Cessation Counseling
35-min counseling by trained research nurse
Ostatní jména:
  • Behaviorální poradenství
Komparátor placeba: 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.
Behaviorální: Smoking Cessation Counseling
35-min counseling by trained research nurse
Ostatní jména:
  • Behaviorální poradenství
Lék: Placebo
Matching Bupropion SR placebo tablet
Ostatní jména:
  • Řízení

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The University of Texas Medical Branch, Galveston

Spolupracovníci

National Institute on Drug Abuse (NIDA)
UConn Health

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2011

Primární dokončení (Aktuální)

1. prosince 2016

Dokončení studie (Aktuální)

1. prosince 2016

Termíny zápisu do studia

První předloženo

8. června 2011

První předloženo, které splnilo kritéria kontroly kvality

6. července 2011

První zveřejněno (Odhad)

8. července 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. června 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. června 2019

Naposledy ověřeno

1. února 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 10-217
  • R01DA030998 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

No plan

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