Postpartum Smoking RelapsePhase 4NCT04098874
Bupropion for the Prevention of Postpartum Smoking Relapse
A Phase 4 study testing Bupropion Extended Release Oral Tablet in people with Postpartum Smoking Relapse, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Smoking Relapse
- What is being tested?
- Bupropion Extended Release Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- Family history of seizures or seizure disorder
- Maternal use of medications that lower seizure threshold
- Newborn with an elevated risk of seizure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
- Being tested
- Bupropion Extended Release Oral Tablet, Placebo oral tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion Extended Release Oral TabletDrug
12 weeks postpartum of blinded study medication
Placebo oral tabletDrug
12 weeks postpartum of blinded placebo
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Experimental | Participants randomized to extended-release bupropion. Once-daily Receives: Drug: Bupropion Extended Release Oral Tablet |
| Placebo | Placebo comparator | Participants randomized to placebo. Once-daily Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence smoking abstinence
7-day point prevalence abstinence
Measured: 24 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Jan 2020
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Smoking RelapseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sharon Allen, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098874
- Sponsor's protocol ID
- FMCH-2019-28219
- Other IDs
- R01DA047287
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2019
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only de-identified data collected in this trial may be available to other researchers. Requests for data will be considered on an individual basis by the study team.
Publications
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.
PubMed 33706003
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion for the Prevention of Postpartum Smoking Relapse
- ClinicalTrials.gov ID
- NCT04098874
- Acronym / sponsor ID
- FMCH-2019-28219
- Conditions
- Postpartum Smoking Relapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Experimental | Drug: Bupropion Extended Release Oral TabletParticipants randomized to extended-release bupropion. Once-daily |
| Placebo | Placebo comparator | Drug: Placebo oral tabletParticipants randomized to placebo. Once-daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion Extended Release Oral Tablet12 weeks postpartum of blinded study medication | Drug | Bupropion |
| Placebo oral tablet12 weeks postpartum of blinded placebo | Drug | Placebo |
Primary outcome
Point prevalence smoking abstinence
Time frame: 24 weeks post randomization
7-day point prevalence abstinence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 33706003Allen 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.
- Individual participant dataSharing planned: Undecided. Only de-identified data collected in this trial may be available to other researchers. Requests for data will be considered on an individual basis by the study team.
Related trials for Postpartum Smoking Relapse
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Recruiting
Prevention of Postpartum Smoking Relapse and Related Health Consequences by Breastfeeding Promotion
Smoking ( Cigarette), Breastfeeding
Recruiting
The Effect of Motivational Interviewing and Digital Game-Supported Counseling on Postpartum Relapse
Postpartum Period, Smoking Relapse Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Allen, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupropion Extended Release Oral Tablet in people with Postpartum Smoking Relapse, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence smoking abstinence (time frame: 24 weeks post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04098874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.