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Bupropion for the Prevention of Postpartum Smoking Relapse

Primary Purpose

Postpartum Smoking Relapse

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupropion Extended Release Oral Tablet
Placebo oral tablet
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Smoking Relapse

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bupropion

Placebo

Arm Description

Participants randomized to extended-release bupropion. Once-daily

Participants randomized to placebo. Once-daily

Outcomes

Primary Outcome Measures

Point prevalence smoking abstinence
7-day point prevalence abstinence

Secondary Outcome Measures

Full Information

First Posted
September 19, 2019
Last Updated
August 2, 2023
Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04098874
Brief Title
Bupropion for the Prevention of Postpartum Smoking Relapse
Official Title
Bupropion for the Prevention of Postpartum Smoking Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Smoking Relapse

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bupropion
Arm Type
Experimental
Arm Description
Participants randomized to extended-release bupropion. Once-daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to placebo. Once-daily
Intervention Type
Drug
Intervention Name(s)
Bupropion Extended Release Oral Tablet
Intervention Description
12 weeks postpartum of blinded study medication
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
12 weeks postpartum of blinded placebo
Primary Outcome Measure Information:
Title
Point prevalence smoking abstinence
Description
7-day point prevalence abstinence
Time Frame
24 weeks post randomization

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Individuals eligible for this study must be pregnant at the time of enrollment.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Harrison, MPH
Phone
612-624-5377
Email
harr0644@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Allen, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Allen, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Only de-identified data collected in this trial may be available to other researchers. Requests for data will be considered on an individual basis by the study team.
Citations:
PubMed Identifier
33706003
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.
Results Reference
derived

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Bupropion for the Prevention of Postpartum Smoking Relapse

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