Non-Nicotine Agents for Smoking Cessation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Tobacco Use Disorder

Keywords

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smoking nicotine drug therapy smoking cessation

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bupropion and transdermal patch

Intervention Type DRUG

transdermal patch and nicotine inhaler

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Denver VA Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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ADRD-013-01S

Identifier Type: -

Identifier Source: org_study_id