Actively Recruiting
Bupropion for the Prevention of Postpartum Smoking Relapse
Led by University of Minnesota · Updated on 2026-01-07
200
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
Sponsors
U
University of Minnesota
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This two-arm, double-blind, placebo-controlled randomized clinical trial will enroll pregnant women who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. Participants will be randomized to receive extended-release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post-randomization). All participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post-randomization and at weeks 12, 24, 36 and 52 post-randomization.
CONDITIONS
Official Title
Bupropion for the Prevention of Postpartum Smoking Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent
- Age 18 to 45 years old
- Stable health
- 7-day smoking abstinence at randomization
- History of smoking at least 100 cigarettes in lifetime
- Quit smoking during current pregnancy
- Intention to remain abstinent after delivery (score of 7 or higher on a 10-point scale)
- Uncomplicated delivery
- No plans for another pregnancy during the trial
- Full-term delivery of 37 weeks gestation or more
- Home within 10 days after delivery
You will not qualify if you...
- Current use of tobacco or nicotine products other than cigarettes (e-cigarettes, chew, snuff, etc.)
- Current use of smoking cessation aids like varenicline or nicotine replacement therapy
- Current use of illicit drugs or alcohol dependence
- Current use of antidepressant medication
- Diagnosis of bipolar disorder, eating disorder, or psychotic disorder
- Medications or medical conditions increasing risk with bupropion (e.g., history of pulmonary embolus, stroke, heart or kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of CYP2D6-metabolized drugs)
- Family history of seizures or personal seizure disorder
- Maternal use of medications lowering seizure threshold
- Newborn with elevated risk of seizure
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
K
Katherine Harrison, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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