Nicotine Replacement and Counseling In Adolescents | NCT00625794

Studies
Nicotine Replacement and Counseling In Adolescents

NCT00625794

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Feb 28, 2008Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Smoking Cessation

Interventions

Nicotine nasal spray
Smoking cessation counseling

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

ID	Type	Description	Link
1K23RR018471	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2007

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

Sep 2005

Primary Completion Date

May 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Feb 19, 2008

First Submission Date that Met QC Criteria

Feb 27, 2008

First Posted Date

Feb 28, 2008Estimated

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

Feb 27, 2008

Last Update Posted Date

Feb 28, 2008Estimated

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 objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	8 weeks or counseling plus 6 weeks of nicotine nasal spray	Drug: Nicotine nasal spray
2	Active Comparator	8 weeks or counseling only.	Behavioral: Smoking cessation counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nicotine nasal spray	Drug	8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Acceptability of the Nicotine Nasal Spray by Adolescents.		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be between 15 and 18 years-old
Smoke 5 or more cigarettes per day (cpd) for at least 6 months and want to quit smoking.

Exclusion Criteria:

Adolescents who were using or had used nicotine replacement in the prior week were excluded.
Those who used bupropion (Zyban®) within the past 30 days were also excluded.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Rubinstein, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF		San Francisco	California	94118	United States

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061485	Tobacco Use Cessation Devices

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided