Brain Reaction to Treatment of Nicotine Dependence | NCT00108173

Studies
Brain Reaction to Treatment of Nicotine Dependence

NCT00108173

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Apr 9, 2013Estimated

Enrollment

104Actual

Phase

Phase 1

Conditions

Nicotine Dependence

Interventions

Zyban

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

Apr 2013

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 2002

Primary Completion Date

Apr 2007Actual

Completion Date

Jun 2011Actual

First Submitted Date

Apr 14, 2005

First Submission Date that Met QC Criteria

Apr 14, 2005

First Posted Date

Apr 15, 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 5, 2013

Last Update Posted Date

Apr 9, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study was to determine how the treatments for cigarette craving work.

Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater reductions in regional brain activation from before to after both forms of active treatments than from before to after placebo.

Detailed Description

PET and fMRI scanning were used to examine brain activity and activation in cigarette smokers in response to cigarette-related cues.

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 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Label	Type	Description	Intervention Names
Arm 1	Other		Drug: Zyban

Name	Type	Description	Arm Group Labels	Other Names
Zyban	Drug		Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
2-FA PET scan results	Brain activity and activation in response to cigarette-related cues	Within the first few weeks of study initiation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heavy smoker, more than one pack per day
Free of medical conditions or medications that affect brain activity
Not pregnant

Exclusion Criteria:

Drug or alcohol dependence Mental Illness Pregnancy Medications that affect brain function Unstable medical conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arthur L. Brody, MD	VA Greater Los Angeles Healthcare System, West LA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Greater Los Angeles Healthcare System, West LA		West Los Angeles	California	90073	United States

Condition Browse Module

MeSH Terms

ID	Term
D014029	Tobacco Use Disorder

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016642	Bupropion

Ancestor Terms

ID	Term
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided