ClinicalTrials.gg
CompletedNCT00108537Updated Apr 4, 2008

Non-Nicotine Agents for Smoking Cessation

A Phase 3 interventional study of bupropion and transdermal patch and transdermal patch and nicotine inhaler in Tobacco Use Disorder, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-04-04.

Sponsored by US Department of Veterans Affairs · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The primary objective of this study is to determine which is the better approach to smoking cessation in veterans: bupropion combined with transdermal nicotine or high dose nicotine replacement therapy (NRT) using transdermal nicotine combined with nicotine inhaler.

Read the detailed description

This study is a two-arm open-label, randomized controlled trial of bupropion combined with transdermal nicotine versus high dose NRT (transdermal nicotine and nicotine inhaler) with all subjects receiving a behavioral counseling program for smoking cessation.

02

Conditions studied

  • Tobacco Use Disorder

Keywords

  • smoking
  • nicotine
  • drug therapy
  • smoking cessation
03

In context

Tobacco Use Disorder

988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.

Browse Tobacco Use Disorder studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 675 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Readiness to set a quit date in the next two weeks,
  • Current smoking of at least 15 cigarettes a day

Exclusion criteria

Exclusion Criteria:

  • Current untreated depression or receiving treatment for depression,
  • History of seizures, major head injury, or other predisposition for seizures
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
None (open label)

Interventions

06

Study locations

1 site
  • Denver VA Medical Center
    Denver, Colorado 80220, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2003 and a completion of Sep 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2005
First posted
Apr 18, 2005
Start
Oct 2003
Completion
Sep 2005
Last update
Apr 4, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Apr 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00108537
First posted
Apr 18, 2005
Start date
Oct 2003
Completion
Sep 2005
Last update
Apr 4, 2008
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2006. You cannot join it, but the record below documents what was studied.

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Discussion

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