Phase 4
Completed N=65
Bupropion for Smoking Cessation During Pregnancy
Pregnancy Related · Tobacco Use
Source: ClinicalTrials.gov NCT01390246 ↗
Enrolled (actual)
65
Serious AEs
10.8%
Results posted
Feb 2018
Primary outcomePrimary: Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment — 1.50; 2.07; 3.77; 5.35 MNWS Score
◆ Published Evidence
Established
33citations · ~4 / year
Bupropion sustained release for pregnant smokers: a randomized, placebo-controlled trial.
Summary
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.
Linked Publications
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Bupropion sustained release for pregnant smokers: a randomized, placebo-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment |
1.50; 2.07; 3.77; 5.35 | — |
| PRIMARY Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date |
2.04; 2.33; 4.75; 4.88 | — |
| PRIMARY Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6) |
5; 1 | — |
| PRIMARY Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7) |
3; 1 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01390246) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.