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NCT00108537 Clinical Trial

Non-Nicotine Agents for Smoking Cessation

Tobacco Use Disorder Clinical Trial

Official title:
Non-Nicotine Agents for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00108537
Other study ID # ADRD-013-01S
Secondary ID
Status Completed
Phase Phase 3
First received April 15, 2005
Last updated April 2, 2008
Start date October 2003
Est. completion date September 2005

Study information
Verified date October 2006
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Readiness to set a quit date in the next two weeks,

- Current smoking of at least 15 cigarettes a day

Exclusion Criteria:

- Current untreated depression or receiving treatment for depression,

- History of seizures, major head injury, or other predisposition for seizures

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• bupropion and transdermal patch

• transdermal patch and nicotine inhaler

Locations
Country Name City State
United States Denver VA Medical Center Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

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