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NCT01390246 · ClinicalTrials.gov registry record · Phase 4
Bupropion for Smoking Cessation During Pregnancy
A Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
NCT01390246: Completed Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
NCT01390246 is a Phase 4 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 65 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01390246, a Phase 4 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
Study 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.
Primary Outcome
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 tot
Interventions
- DRUG Placebo
- BEHAVIORAL Smoking Cessation Counseling
- DRUG Bupropion SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2011-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
What the finished NCT01390246 record still lists
NCT01390246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01390246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01390246 about?
NCT01390246 is a clinical study titled "Bupropion for Smoking Cessation During Pregnancy". 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.
What is the current status of trial NCT01390246?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2011-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01390246?
The interventions under investigation include: Placebo (DRUG), Smoking Cessation Counseling (BEHAVIORAL), Bupropion SR (DRUG).
Who is sponsoring clinical trial NCT01390246?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01390246's enrollment target sits among peer trials
65 1091st of 2000 higher than 903 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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