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Antidepressant

Bupropion for Smoking Relapse

Phase 4

Recruiting

Led By Sharon Allen, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 40 years old

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks post randomization

Awards & highlights

Study Summary

This trial will enroll pregnant women who recently quit smoking and want to stay abstinent. They will be given either a placebo or extended-release bupropion, and the effects will be monitored through questionnaires and biological sample analysis.

Who is the study for?

This trial is for women aged 18-40 who quit smoking during pregnancy, had a full-term and uncomplicated delivery, and are motivated to avoid smoking postpartum. They must not plan to get pregnant again soon, use other tobacco or cessation aids, have certain mental health conditions or take medications that could interact with the trial drug.Check my eligibility

What is being tested?

The study tests if Bupropion can prevent new moms from starting to smoke again after giving birth. Half will receive Bupropion and half a placebo (a dummy pill), without knowing which one they're taking. The treatment starts shortly after childbirth and continues for 12 weeks.See study design

What are the potential side effects?

Bupropion may cause side effects like dry mouth, headaches, difficulty sleeping, increased blood pressure, risk of seizures in susceptible individuals, and possible mood changes. Not everyone will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 40 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Point prevalence smoking abstinence

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BupropionExperimental Treatment1 Intervention

Participants randomized to extended-release bupropion. Once-daily

Group II: PlaceboPlacebo Group1 Intervention

Participants randomized to placebo. Once-daily

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,469 Previous Clinical Trials

2,619,209 Total Patients Enrolled

University of MinnesotaLead Sponsor

1,380 Previous Clinical Trials

1,588,545 Total Patients Enrolled

Sharon Allen, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

Bupropion Extended Release Oral Tablet (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT04098874 — Phase 4

Smoking Relapse Research Study Groups: Placebo, Bupropion

Smoking Relapse Clinical Trial 2023: Bupropion Extended Release Oral Tablet Highlights & Side Effects. Trial Name: NCT04098874 — Phase 4

Bupropion Extended Release Oral Tablet (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04098874 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical issues is Bupropion Extended Release Oral Tablet generally recommended?

"Bupropion Extended Release Oral Tablet has been used, with varying degrees of success, to address seasonal affective disorder as well as aid in smoking cessation."

Answered by AI

How many individuals are engaging with this experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is presently recruiting participants; it was initially posted on January 1st 2020 and revised lastly on July 12th 2022. Specifically, the study requires 200 patients from a single location."

Answered by AI

Is there precedent for the use of Bupropion Extended Release Oral Tablet in prior clinical experiments?

"Currently, there are 31 investigations ongoing for Bupropion Extended Release Oral Tablet with 10 of them in their final stage. Most trials are taking place at New Haven (CT), yet 283 other sites have been enlisted to run the experiments."

Answered by AI

Is it possible for me to be a part of this research endeavor?

"This clinical trial is accepting 200 participants who have relapsed on smoking postpartum. The age range of candidates should be between 18 and 40, with a lifetime history of 100 cigarettes smoked being mandatory. Additionally, an intention to remain abstinent after delivery must score at least 7/10 on the Likert-type scale; uncomplicated delivery that was full term (37+ weeks) is also necessary for entry into this study. Prospective applicants must deny any plans to become pregnant again during this trial's duration."

Answered by AI

How does Bupropion Extended Release Oral Tablet impact patient health over time?

"This treatment has already been approved for medical use, so it earned a safety rating of 3."

Answered by AI

Are elderly people being accepted for the experiment?

"For this trial, the minimum age requirement is 18 years while the maximum is 40."

Answered by AI

Are there any vacancies available for participants of this clinical trial?

"Clinicaltrials.gov confirms that this clinical trial is actively seeking out participants; the listing was first made available on January 1st 2020 and has been revised as recently as July 12th 2022."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

Bupropion for Postpartum Smoking Relapse: A Remote Protocol for a Two-arm, Double-blind, Placebo-controlled Randomized Clinical Trial

Allen, Sharon, Janet Thomas, Katherine Harrison, Rebecca L. Emery, Ashley Petersen, Jonathan P. Winickoff, and Sandra Japuntich. 2021. “Bupropion for Postpartum Smoking Relapse: A Remote Protocol for a Two-arm, Double-blind, Placebo-controlled Randomized Clinical Trial”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106352.

clinicaltrials.govStudy

Bupropion for the Prevention of Postpartum Smoking Relapse

2020. "Bupropion for the Prevention of Postpartum Smoking Relapse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04098874.

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