Bupropion for the Prevention of Postpartum Smoking Relapse

Postpartum Smoking Relapse Clinical Trial

Official title:

Bupropion for the Prevention of Postpartum Smoking Relapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098874
• Other study ID #: FMCH-2019-28219
• Secondary ID: R01DA047287
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: Katherine Harrison, MPH
• Phone: 612-624-5377
• Email: harr0644[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Ability to provide informed consent

• Age 18 to 40 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

Related Conditions & MeSH terms

• Postpartum Smoking Relapse
• Recurrence

Intervention

Drug:
• Bupropion Extended Release Oral Tablet
12 weeks postpartum of blinded study medication
• Placebo oral tablet
12 weeks postpartum of blinded placebo

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence smoking abstinence	7-day point prevalence abstinence	24 weeks post randomization