Bupropion for the Prevention of Postpartum Smoking Relapse

Study Overview
=================
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.

Official Title
-----------------
Bupropion for the Prevention of Postpartum Smoking Relapse

Conditions
-----------------
Postpartum Smoking Relapse

Intervention / Treatment
-----------------
* Drug: Bupropion Extended Release Oral Tablet
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion<br>Participants randomized to extended-release bupropion. Once-daily | Drug: Bupropion Extended Release Oral Tablet<br>* 12 weeks postpartum of blinded study medication<br>|
| Placebo Comparator: Placebo<br>Participants randomized to placebo. Once-daily | Drug: Placebo oral tablet<br>* 12 weeks postpartum of blinded placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point prevalence smoking abstinence | 7-day point prevalence abstinence | 24 weeks post randomization |