NCT04098874

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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
3mo left

Started Jan 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2020Jul 2026

First Submitted

Initial submission to the registry

September 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

6.6 years

First QC Date

September 19, 2019

Last Update Submit

January 5, 2026

Conditions

Postpartum Smoking Relapse

Outcome Measures

Primary Outcomes (1)

  • Point prevalence smoking abstinence

    7-day point prevalence abstinence

    24 weeks post randomization

Study Arms (2)

Bupropion

EXPERIMENTAL

Participants randomized to extended-release bupropion. Once-daily

Drug: Bupropion Extended Release Oral Tablet

Placebo

PLACEBO COMPARATOR

Participants randomized to placebo. Once-daily

Drug: Placebo oral tablet

Interventions

Bupropion Extended Release Oral TabletDRUG

12 weeks postpartum of blinded study medication

Bupropion
Placebo oral tabletDRUG

12 weeks postpartum of blinded placebo

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIndividuals eligible for this study must be pregnant at the time of enrollment.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to provide informed consent
  • Age 18 to 45 years old
  • Stable health
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Related Publications (1)

  • Allen S, Thomas J, Harrison K, Emery RL, Petersen A, Winickoff JP, Japuntich S. Bupropion for postpartum smoking relapse: A remote protocol for a two-arm, double-blind, placebo-controlled randomized clinical trial. Contemp Clin Trials. 2021 Jun;105:106352. doi: 10.1016/j.cct.2021.106352. Epub 2021 Mar 9.

    PMID: 33706003DERIVED

Study Officials

  • Sharon Allen, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Harrison, MPH

CONTACT

612-624-5377harr0644@umn.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 23, 2019

Study Start

January 1, 2020

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

US(1)