Status:
RECRUITING
Bupropion for the Prevention of Postpartum Smoking Relapse
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Postpartum Smoking Relapse
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
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. P...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04098874
Start Date
January 1 2020
End Date
July 31 2026
Last Update
January 7 2026
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455