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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
(KISV) 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.Check my eligibility
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.See study design
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.
(KISV) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Verified abstinence at Month 6
Secondary outcome measures
Adherence to medication
(KISV) 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
463 Previous Clinical Trials
168,770 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:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks are associated with traditional treatment approaches?
"Standard Treatment has been evaluated as a 3 on the 1 to 3 scale due to various clinical trials indicating its efficacy and extensive data affirming its safety."
Answered by AI
Are recruitment efforts for this research endeavor ongoing currently?
"As per clinicaltrials.gov, this trial is no longer enrolling participants. It was initially posted on February 27th 2023 and edited most recently on the 7th of February that same year. However, there are 151 other studies actively seeking volunteers at the moment."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
What site did they apply to?
University of Kansas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Will I be compensated?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
After living with someone who doesn’t smoke cigarettes, I’ve had to cut back on smoking. Having to go outside to smoke instead of staying inside has really made a difference on the amount of cigarettes I smoke now. The smell has seemed to almost be stronger to me and it’s an awful smell. It’s. Abad habit anyways and I could use cigarette money for something useful.
PatientReceived 2+ prior treatments
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