Bupropion for the Prevention of Postpartum Smoking Relapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postpartum Smoking Relapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bupropion

Participants randomized to extended-release bupropion. Once-daily

Group Type EXPERIMENTAL

Bupropion Extended Release Oral Tablet

Intervention Type DRUG

12 weeks postpartum of blinded study medication

Placebo

Participants randomized to placebo. Once-daily

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

12 weeks postpartum of blinded placebo

Interventions

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Bupropion Extended Release Oral Tablet

12 weeks postpartum of blinded study medication

Intervention Type DRUG

Placebo oral tablet

12 weeks postpartum of blinded placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes