Bupropion for the Prevention of Postpartum Smoking Relapse

Phase 4

Recruiting

• Conditions: Postpartum Smoking Relapse
• Interventions: Drug: Bupropion Extended Release Oral Tablet; Drug: Placebo oral tablet

• Registration Number: NCT04098874
• Lead Sponsor: University of Minnesota

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-23
• Study Start: 2020-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupropion	Bupropion Extended Release Oral Tablet	Participants randomized to extended-release bupropion. Once-daily
Placebo	Placebo oral tablet	Participants randomized to placebo. Once-daily

Primary Outcome Measures

Name	Time	Method
Point prevalence smoking abstinence	24 weeks post randomization	7-day point prevalence abstinence

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States