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Non-Nicotine Agents for Smoking Cessation

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
bupropion and transdermal patch
transdermal patch and nicotine inhaler
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring smoking, nicotine, drug therapy, smoking cessation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denver VA Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 15, 2005
Last Updated
April 2, 2008
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00108537
Brief Title
Non-Nicotine Agents for Smoking Cessation
Official Title
Non-Nicotine Agents for Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
smoking, nicotine, drug therapy, smoking cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bupropion and transdermal patch
Intervention Type
Drug
Intervention Name(s)
transdermal patch and nicotine inhaler

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States

12. IPD Sharing Statement

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Non-Nicotine Agents for Smoking Cessation

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