Nicotine Replacement and Counseling In Adolescents

NCT ID: NCT00625794

Last Updated: 2008-02-28

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

8 weeks or counseling plus 6 weeks of nicotine nasal spray

Group Type EXPERIMENTAL

Nicotine nasal spray

Intervention Type DRUG

8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).

2

8 weeks or counseling only.

Group Type ACTIVE_COMPARATOR

Smoking cessation counseling

Intervention Type BEHAVIORAL

8 weeks or counseling

Interventions

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Nicotine nasal spray

8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).

Intervention Type DRUG

Smoking cessation counseling

8 weeks or counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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UCSF

Principal Investigators

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Mark Rubinstein, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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1K23RR018471

Identifier Type: NIH

Identifier Source: secondary_id

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1K23RR018471

Identifier Type: NIH

Identifier Source: org_study_id

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