Bupropion for the Prevention of Postpartum Smoking Relapse

• ClinicalTrials.gov Identifier: NCT04098874
• Recruitment Status: Recruiting
• First Posted: September 23, 2019
• Last Update Posted: July 13, 2022
• Sponsor: University of Minnesota
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): University of Minnesota

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Sharon Allen, MD; University of Minnesota

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: July 13, 2022
• Last Verified: July 2022

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.

• 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:

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