NCT04098874 · University of Minnesota
Bupropion for the Prevention of Postpartum Smoking Relapse
What this study is about
This two-treatment group$1, where neither patients nor doctors know which treatment is given, compared against an inactive treatment randomly assigned clinical trial will enroll pregnant women who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum.
View original scientific description
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.
Interventions
DRUG
Bupropion Extended Release Oral Tablet
12 weeks postpartum of blinded study medication
DRUG
Placebo oral tablet
12 weeks postpartum of blinded placebo
Primary outcome measures
Point prevalence smoking abstinence
Time frame: 24 weeks post randomization
7-day point prevalence abstinence
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ability to provide informed consent
- Age 18 to 45 years old
- Stable health
- 7-day point prevalence abstinence demonstrated at randomization
- Lifetime history of at least 100 cigarettes smoked
- Quit smoking during the current pregnancy
- Self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
- Uncomplicated delivery
- Denies plans to become pregnant again during the trial.
- Full-term delivery ≥ 37 weeks gestation
- Home within 10 days of delivery
Exclusion criteria
- Current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
- Current use of cessation aids (e.g., varenicline, NRT)
- Current use of illicit drugs or alcohol dependence
- Current use of antidepressant medication
- Bipolar disorder, eating disorder, or psychotic disorder based on the Structured Clinical Interview
- Medications \& conditions that may increase the risk of taking bupropion (e.g., current or history of pulmonary embolus, stroke, heart disease, kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of medications metabolized by CYP2D6)
- Family history of seizures or seizure disorder
- Maternal use of medications that lower seizure threshold
- Newborn with an elevated risk of seizure
Where
- Minneapolis, Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations