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NCT Number: NCT04098874

Bupropion for the Prevention of Postpartum Smoking Relapse

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.

Recruiting

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Key information

Conditions

Postpartum Smoking Relapse

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Sharon Allen, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupropion Extended Release Oral Tablet

Drug

12 weeks postpartum of blinded study medication

Placebo oral tablet

Drug

12 weeks postpartum of blinded placebo

Primary outcomes

  1. Point prevalence smoking abstinence

    Time frame: 24 weeks post randomization

    7-day point prevalence abstinence

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine Harrison, MPH

CONTACT

[email protected]

612-624-5377

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2019
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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