Clinical trial NCT04098874: Bupropion for the Prevention of Postpartum Smoking Relapse
Official title: Bupropion for the Prevention of Postpartum Smoking Relapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postpartum Smoking Relapse
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-09-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Point prevalence smoking abstinence
timeFrame: 24 weeks post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sharon Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen S, Thomas J, Harrison K, Emery RL, Petersen A, Winickoff JP, Japuntich S. Bupropion for postpartum smoking relapse: A remote protocol for a two-arm, double-blind, placebo-controlled randomized clinical trial. Contemp Clin Trials. 2021 Jun;105:106352. doi: 10.1016/j.cct.2021.106352. Epub 2021 Mar 9.