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...
Date First Received: February 19, 2008
Last Updated: February 27, 2008
Verified by: University of California, San Francisco, May 2007
Clinical Trial Phase: Phase 4 | Start Date: September 2005
Overall Status: Completed
Estimated Enrollment: 40
Brief Summary
Official Title: “A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: May 2007
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- 8 weeks or counseling plus 6 weeks of nicotine nasal spray
- Active Comparator: 2
- 8 weeks or counseling only.
Outcome Measures for this Clinical Trial
Primary Measures
- Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Secondary Measures
- Acceptability of the Nicotine Nasal Spray by Adolescents.
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 15 Years
Maximum Age for this Clinical Trial: 18 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of California, San Francisco
Overall Clinical Trial Officials and Contacts
Mark Rubinstein, MD Principal Investigator University of California, San Francisco
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00625794
Study ID Number: 1K23 RR18471
ClinicalTrials.gov Identifier: NCT00625794
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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