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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
Must not have
Newborn with an elevated risk of seizure
Current use of antidepressant medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks post randomization
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My newborn is at high risk for seizures.
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I am currently taking antidepressant medication.
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I am currently using aids to help me stop smoking.
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I have a family history of seizures.
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I have taken medications that could increase my risk of seizures.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Point prevalence smoking abstinence

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,735 Total Patients Enrolled
University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,758 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
~0 spots leftby Jan 2025
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