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Nicotine Replacement and Counseling In Adolescents

Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Smoking Cessation

Intervention: Nicotine nasal spray (Drug); Smoking cessation counseling (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Mark Rubinstein, MD, Principal Investigator, Affiliation: University of California, San Francisco

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.

Clinical Details

Official title: A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.

Secondary outcome: Acceptability of the Nicotine Nasal Spray by Adolescents.

Eligibility

Minimum age: 15 Years. Maximum age: 18 Years. Gender(s): Both.

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.

Locations and Contacts

UCSF, San Francisco, California 94118, United States
Additional Information

Starting date: September 2005
Ending date: July 2007
Last updated: February 27, 2008

Page last updated: June 20, 2008

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