RECRUITING

Bupropion for the Prevention of Postpartum Smoking Relapse

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Bupropion for the Prevention of Postpartum Smoking Relapse

Quick Facts

Study Start:2020-01-01
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04098874

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide informed consent
  2. * Age 18 to 45 years old
  3. * Stable health
  4. * 7-day point prevalence abstinence demonstrated at randomization
  5. * Lifetime history of at least 100 cigarettes smoked
  6. * Quit smoking during the current pregnancy
  7. * Self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
  8. * Uncomplicated delivery
  9. * Denies plans to become pregnant again during the trial.
  10. * Full-term delivery ≥ 37 weeks gestation
  11. * Home within 10 days of delivery
  1. * Current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
  2. * Current use of cessation aids (e.g., varenicline, NRT)
  3. * Current use of illicit drugs or alcohol dependence
  4. * Current use of antidepressant medication
  5. * Bipolar disorder, eating disorder, or psychotic disorder based on the Structured Clinical Interview
  6. * 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)
  7. * Family history of seizures or seizure disorder
  8. * Maternal use of medications that lower seizure threshold
  9. * Newborn with an elevated risk of seizure

Contacts and Locations

Study Contact

Katherine Harrison, MPH
CONTACT
612-624-5377
harr0644@umn.edu

Principal Investigator

Sharon Allen, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Sharon Allen, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-01
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2020-01-01
Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Postpartum Smoking Relapse