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Antidepressant

BUP-450 for Smoking Cessation

Phase 2
Waitlist Available
Led By Adam M Leventhal, PhD
Research Sponsored by University of Southern California
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 through study completion, an average of 26 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing two doses of Bupropion to help smokers quit. Participants will take either 300 mg or 450 mg of the medication for a few months, along with counseling. Bupropion helps reduce cravings and withdrawal symptoms by affecting brain chemicals. The study will follow up with participants to see how well they stick to quitting. Bupropion, initially developed as an antidepressant, has been shown to help increase the ability of smokers to quit.

Eligible Conditions
  • Smoking Cessation
  • Smoking/Cigarette Smoking
  • Tobacco Smoking
  • Smoking Addiction
  • Tobacco Cessation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 26 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 26 months 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 Abstinence (PPA) [change in abstinence reports will be assessed]
Secondary study objectives
Body adiposity via bioimpedence monitor
Inventory of Depressive and Anxious Symptomology (General depression subscale)
Inventory of Depressive and Anxious Symptomology (Social anxiety subscale)
+5 more

Side effects data

From 2021 Phase 1 trial • 54 Patients • NCT04526210
4%
Nausea
2%
Agitation
2%
Anal haemorrhage
2%
Vomiting
2%
Diarrhoea
2%
Constipation
2%
Toothache
2%
Skin irritation
2%
Back pain
2%
Oral herpes
2%
Chalazion
2%
Abdominal discomfort
2%
Abdominal pain upper
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment A: Bupropion HCl
Treatment B: Bupropion HCl + ALXN1840

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BUP-450Experimental Treatment1 Intervention
Participants will receive Bupropion hydrochloride for 12 weeks and titrate to a maximum dose of 450 mg/day and will also receive standard smoking cessation counseling for 8 weeks.
Group II: BUP-300Active Control1 Intervention
Participants will receive Bupropion hydrochloride for 10 weeks and titrate to a maximum dose of 300 mg/day and will also receive standard smoking cessation counseling for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupropion Hydrochloride
2020
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,560 Previous Clinical Trials
10,258,922 Total Patients Enrolled
University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,633 Total Patients Enrolled
University of California, San DiegoOTHER
1,177 Previous Clinical Trials
1,573,586 Total Patients Enrolled
~3 spots leftby Nov 2025
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