Postpartum Smoking Relapse
Conditions
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.
Interventions
DRUGBupropion Extended Release Oral Tablet
12 weeks postpartum of blinded study medication
DRUGPlacebo oral tablet
12 weeks postpartum of blinded placebo
Sponsors
University of Minnesota
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Point prevalence smoking abstinence | 24 weeks post randomization | 7-day point prevalence abstinence |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSharon Allen, MD
University of Minnesota
Outcome results
None listed