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Bupropion for the Prevention of Postpartum Smoking Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098874
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : June 30, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Postpartum Smoking Relapse Drug: Bupropion Extended Release Oral Tablet Drug: Placebo oral tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Bupropion for the Prevention of Postpartum Smoking Relapse
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Bupropion
Participants randomized to extended-release bupropion. Once-daily
Drug: Bupropion Extended Release Oral Tablet
12 weeks postpartum of blinded study medication

Placebo Comparator: Placebo
Participants randomized to placebo. Once-daily
Drug: Placebo oral tablet
12 weeks postpartum of blinded placebo




Primary Outcome Measures :
  1. Point prevalence smoking abstinence [ Time Frame: 24 weeks post randomization ]
    7-day point prevalence abstinence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Individuals eligible for this study must be pregnant at the time of enrollment.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098874


Contacts
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Contact: Katherine Harrison, MPH 612-624-5377 harr0644@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Sharon Allen, MD         
Sponsors and Collaborators
University of Minnesota
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Sharon Allen, MD University of Minnesota
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04098874    
Other Study ID Numbers: FMCH-2019-28219
R01DA047287 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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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
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors