Bupropion for the Prevention of Postpartum Smoking Relapse

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.

Conditions

Postpartum Smoking Relapse

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Study Overview

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Study Details

Study overview

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.

Bupropion for the Prevention of Postpartum Smoking Relapse

Bupropion for the Prevention of Postpartum Smoking Relapse

Condition
Postpartum Smoking Relapse
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Minnesota,

Sharon Allen, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2025-01-01