Nicotine Replacement and Counseling In Adolescents

Verified by: University of California, San Francisco, May 2007
First Received: February 19, 2008 | Last Updated: February 27, 2008 | Phase: Phase 4 | Start Date: September 2005
Overall Status: Completed | Estimated Enrollment: 40
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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...

Brief Summary

Official Title: “A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers”

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

Secondary Measures

  • Acceptability of the Nicotine Nasal Spray by Adolescents.
    • Time Frame: 8 weeks
      Safety Issue?: No

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 Investigator Information

Lead Investigator: University of California, San Francisco Other

Overall Clinical Trial Officials and Contacts

Mark Rubinstein, MD Principal Investigator University of California, San Francisco  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00625794