Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Bupropion for Smoking Cessation During Pregnancy

5. juni 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

65

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Galveston, Texas, Forente stater, 77555
        • University of Texas Medical Branch at Galveston

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Legemiddel: Bupropion SR
Bupropion SR 150 mg tablet
Andre navn:
  • Zyban
  • buproban
Atferdsmessig: Smoking Cessation Counseling
35-min counseling by trained research nurse
Andre navn:
  • Adferdsrådgivning
Placebo komparator: 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.
Atferdsmessig: Smoking Cessation Counseling
35-min counseling by trained research nurse
Andre navn:
  • Adferdsrådgivning
Legemiddel: Placebo
Matching Bupropion SR placebo tablet
Andre navn:
  • Styre

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The University of Texas Medical Branch, Galveston

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)
UConn Health

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2011

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. desember 2016

Datoer for studieregistrering

Først innsendt

8. juni 2011

Først innsendt som oppfylte QC-kriteriene

6. juli 2011

Først lagt ut (Anslag)

8. juli 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juni 2019

Sist bekreftet

1. februar 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 10-217
  • R01DA030998 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No plan

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere