- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01390246
Bupropion for Smoking Cessation During Pregnancy
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Texas
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Galveston, Texas, Förenta staterna, 77555
- University of Texas Medical Branch at Galveston
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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. |
Bupropion SR 150 mg tablet
Andra namn:
35-min counseling by trained research nurse
Andra namn:
|
Placebo-jämförare: 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. |
35-min counseling by trained research nurse
Andra namn:
Matching Bupropion SR placebo tablet
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Gary DV Hankins, MD, University of Texas Medical Branch at Galveston
- Huvudutredare: Tatiana Nanovskaya, PhD, University of Texas Medical Branch at Galveston
- Huvudutredare: Cheryl Onken, MD, MPH, UConn Health
- Huvudutredare: Mahmoud Ahmed, PhD, University of Texas Medical Branch at Galveston
- Huvudutredare: Shannon Clark, MD, University of Texas Medical Branch at Galveston
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Kemiskt inducerade störningar
- Substansrelaterade störningar
- Störning av tobaksbruk
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Psykotropa droger
- Neurotransmittorupptagshämmare
- Membrantransportmodulatorer
- Antidepressiva medel
- Dopaminmedel
- Cytokrom P-450 enzymhämmare
- Antidepressiva medel, andra generationen
- Cytokrom P-450 CYP2D6-hämmare
- Dopaminupptagshämmare
- Bupropion
Andra studie-ID-nummer
- 10-217
- R01DA030998 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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