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NCT00625794 Clinical Trial

Nicotine Replacement and Counseling In Adolescents

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00625794
Other study ID # 1K23RR018471
Secondary ID 1K23RR018471
Status Completed
Phase Phase 4
First received February 19, 2008
Last updated February 27, 2008
Start date September 2005
Est. completion date July 2007

Study information
Verified date May 2007
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 2007
Est. primary completion date May 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 18 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nicotine nasal spray
8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).
Behavioral:
• Smoking cessation counseling
8 weeks or counseling

Locations
Country Name City State
United States UCSF San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine. 12 weeks No
Secondary Acceptability of the Nicotine Nasal Spray by Adolescents. 8 weeks No
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