NCT04098874PHASE4RecruitingAccepts Healthy Volunteers

Bupropion for the Prevention of Postpartum Smoking Relapse

University of Minnesota

Start Date

1/1/2020

Completion Date

7/31/2026

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.

Eligibility Criteria

Age Range: 18 years to 45 years

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

Interventions

DRUG

Bupropion Extended Release Oral Tablet

DRUG

Placebo oral tablet

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Conditions

Postpartum Smoking Relapse

Locations

University of Minnesota

Minneapolis, Minnesota 55455

United States