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Completed

NCT Number: NCT00625794

Nicotine Replacement and Counseling In Adolescents

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSF

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine Nasal Spray

Drug

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

Smoking Cessation Counseling

Behavioral

8 weeks or counseling

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Acceptability of the Nicotine Nasal Spray by Adolescents.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 28, 2008
Registry last updated
Feb 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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