Bupropion for the Prevention of Postpartum Smoking Relapse | NCT04098874

Studies
Bupropion for the Prevention of Postpartum Smoking Relapse

NCT04098874

Sponsor

University of Minnesota

Status

Recruiting

Last Update Posted

Jan 7, 2026Actual

Enrollment

200Estimated

Phase

Phase 4

Conditions

Postpartum Smoking Relapse

Interventions

Bupropion Extended Release Oral Tablet
Placebo oral tablet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA047287	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Sep 19, 2019

First Submission Date that Met QC Criteria

Sep 19, 2019

First Posted Date

Sep 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2026

Last Update Posted Date

Jan 7, 2026Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bupropion Extended Release Oral Tablet	Drug	12 weeks postpartum of blinded study medication	Bupropion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Point prevalence smoking abstinence	7-day point prevalence abstinence	24 weeks post randomization

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Individuals eligible for this study must be pregnant at the time of enrollment.

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katherine Harrison, MPH	Contact	612-624-5377		harr0644@umn.edu

Overall Officials

Name	Affiliation	Role
Sharon Allen, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota	Recruiting	Minneapolis	Minnesota	55455	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33706003	Derived	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.