Nicotine Replacement and Counseling In Adolescents

A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00625794

Enrollment

Registered

2008-02-28

Start date

2005-09-30

Completion date

2007-07-31

Last updated

2008-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

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.

Interventions

BEHAVIORALSmoking cessation counseling

8 weeks or counseling

DRUGNicotine nasal spray

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 18 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026