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Anti-depressant
Extended Bupropion Treatment for Smoking Cessation ((KISV) Trial)
Phase 3
Recruiting
Led By Lisa Sanderson Cox, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare 6 months of extended bupropion use to 7 weeks of standard bupropion use to help African American daily smokers quit.
Who is the study for?
This trial is for African American adults who smoke daily, want to quit, and are willing to commit to a 6-month treatment plan. Participants must not be using any stop smoking medications recently, be pregnant or breastfeeding, have had a recent heart attack, or take certain drugs metabolized by the liver enzyme CYP2D6.
What is being tested?
The study compares two durations of bupropion treatment for quitting smoking: an extended course of 6 months versus the standard duration of 7 weeks. It aims to determine which is more effective in helping African American smokers achieve abstinence.
What are the potential side effects?
Bupropion may cause side effects such as dry mouth, trouble sleeping, headache, nausea, constipation and increased risk of seizures. Some people might also experience changes in mood or behavior.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Verified abstinence at Month 6
Secondary study objectives
Adherence to medication
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: Standard TreatmentActive Control1 Intervention
250 participants will be randomly assigned to the standard treatment arm and receive 7 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 7 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines.
Group II: Extended TreatmentActive Control1 Intervention
250 participants will be randomly assigned to the extended treatment arm and receive 24 weeks of bupropion SR following standard dosing guidelines(150 mg once daily for 3 days, then 150mg twice daily for 24 weeks). Participants in this arm will also receive 8 smoking cessation counseling sessions consistent with the Clinical Practice Guidelines.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,399 Total Patients Enrolled
Lisa Sanderson Cox, PhDPrincipal InvestigatorUniversity of Kanas Medical Center
1 Previous Clinical Trials
500 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a heart attack within the last 2 months.You have smoked at least one cigarette per day for over a year.I am not taking any psychoactive medications.I have had seizures or head injuries in the past.I want to quit smoking.My diabetes is not well-controlled.I am not taking medications like metoprolol or tamoxifen that are affected by bupropion.I have smoked more than one cigarette per day for over a year.I have not used any stop smoking medications in the last 30 days.I am older than 18 years.I am willing to take study medication for 6 months and attend all visits.I want to quit.You have smoked on more than 25 days in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Treatment
- Group 2: Extended Treatment
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Smoking Cessation Patient Testimony for trial: Trial Name: NCT05732272 — Phase 3
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