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Nicotine Replacement and Counseling In Adolescents

This study has been completed.
Information provided by:
University of California, San Francisco Identifier:
First received: February 19, 2008
Last updated: February 27, 2008
Last verified: May 2007
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.

Condition Intervention Phase
Smoking Cessation Drug: Nicotine nasal spray Behavioral: Smoking cessation counseling Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Acceptability of the Nicotine Nasal Spray by Adolescents. [ Time Frame: 8 weeks ]

Enrollment: 40
Study Start Date: September 2005
Study Completion Date: July 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
8 weeks or counseling plus 6 weeks of nicotine nasal spray
Drug: Nicotine nasal spray
8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).
Active Comparator: 2
8 weeks or counseling only.
Behavioral: Smoking cessation counseling
8 weeks or counseling


Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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.
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Please refer to this study by its identifier: NCT00625794

United States, California
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Mark Rubinstein, MD University of California, San Francisco
  More Information

Responsible Party: Mark Rubinstein, MD, UCSF Identifier: NCT00625794     History of Changes
Other Study ID Numbers: 1K23RR018471 ( U.S. NIH Grant/Contract )
Study First Received: February 19, 2008
Last Updated: February 27, 2008

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017