Nicotine Replacement and Counseling In Adolescents

Phase 4

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Nicotine nasal spray; Behavioral: Smoking cessation counseling

• Registration Number: NCT00625794
• Lead Sponsor: University of California, San Francisco

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 available

Study Timeline

• Study Start: 2005-09
• Status Verified: 2007-05
• Primary Completion: 2007-05
• Study Completion: 2007-07
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-27
• Last Update Submitted: 2008-02-27
• Study First Posted: 2008-02-28
• Last Update Posted: 2008-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nicotine nasal spray	8 weeks or counseling plus 6 weeks of nicotine nasal spray
2	Smoking cessation counseling	8 weeks or counseling only.

Primary Outcome Measures

Name	Time	Method
Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Acceptability of the Nicotine Nasal Spray by Adolescents.	8 weeks

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States