Non-Nicotine Agents for Smoking Cessation | NCT00108537

Studies
Non-Nicotine Agents for Smoking Cessation

NCT00108537

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Apr 4, 2008Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Tobacco Use Disorder

Interventions

bupropion and transdermal patch
transdermal patch and nicotine inhaler

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Apr 15, 2005

First Submission Date that Met QC Criteria

Apr 15, 2005

First Posted Date

Apr 18, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2008

Last Update Posted Date

Apr 4, 2008Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Denver VA Medical Center		Denver	Colorado	80220	United States

Condition Browse Module

MeSH Terms

ID	Term
D014029	Tobacco Use Disorder
D012907	Smoking
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016642	Bupropion
D057968	Transdermal Patch
D009538	Nicotine

Ancestor Terms

ID	Term
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
bupropion and transdermal patch	Drug
transdermal patch and nicotine inhaler	Drug