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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

Study Summary

This trial will study if Bupropion XL can help heavy smokers who experience psychiatric symptoms.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed]
Secondary outcome measures
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%
Diarrhoea
2%
Back pain
2%
Skin irritation
2%
Anal haemorrhage
2%
Abdominal discomfort
2%
Agitation
2%
Chalazion
2%
Vomiting
2%
Toothache
2%
Constipation
2%
Abdominal pain upper
2%
Oral herpes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment A: Bupropion HCl
Treatment B: Bupropion HCl + ALXN1840

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
1,528 Previous Clinical Trials
10,276,839 Total Patients Enrolled
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,266 Total Patients Enrolled
University of California, San DiegoOTHER
1,120 Previous Clinical Trials
1,521,395 Total Patients Enrolled

Frequently Asked Questions

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

To what extent does Bupropion hydrochloride extended release pose a risk to those taking it?

"Based on the available data, bupropion hydrochloride extended release was rated a 2 for safety. This is because it has been tested in previous clinical trials which provide evidence of its security profile but no proof that it can be effective therapeutically."

Answered by AI

Is it possible for me to join in this clinical experiment?

"This trial is searching for 300 individuals who suffer from anhedonia, aged between 21 and 65. Crucially, candidates must have been smoking at least 10 cigarettes daily for more than 2 years and their breath CO ppm needs to be above 10ppm upon entering the study."

Answered by AI

Does the study accept octogenarians as participants?

"This medical trial is seeking participants who are of legal age (21+) and under the upper limit of 65 years old."

Answered by AI

What medicinal applications does Bupropion hydrochloride extended release typically serve?

"Bupropion hydrochloride extended release is primarily used for the treatment of seasonal affective disorder, however it may also be beneficial in managing smoking cessation and related diseases."

Answered by AI

How many participants have enrolled in the research?

"Unfortunately, this clinical trial is no longer accepting applicants. Its announcement was originally made on June 1st 2020 and it has been since updated as of May 18th 2020. On the other hand, there are 212 trials that are still recruiting participants for anhedonia and 31 studies searching for volunteers to participate in research with Bupropion hydrochloride extended release treatments."

Answered by AI

Could you please provide a synopsis of research conducted utilizing Bupropion hydrochloride extended release?

"Presently, there are 31 clinical trials being conducted in regards to Bupropion hydrochloride extended release. Of these studies, 10 of them are at the Phase 3 level and 283 different medical centres across the globe have been running tests for this treatment, with a majority situated in New Haven, Connecticut."

Answered by AI

Is this experiment currently searching for participants?

"Unfortunately, this clinical trial has already ended its recruitment phase. Initially posted on June 1st 2020 and most recently updated on May 18th 2020, it is no longer open for participation. If you are searching for other studies related to anhedonia, there are currently 212 trials that accept patients; 31 of them involve Bupropion hydrochloride extended release."

Answered by AI
Recent research and studies
~3 spots leftby Apr 2025