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Nicotine Replacement and Counseling In Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00625794
First Posted: February 28, 2008
Last Update Posted: February 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, San Francisco
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625794


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

Responsible Party: Mark Rubinstein, MD, UCSF
ClinicalTrials.gov Identifier: NCT00625794     History of Changes
Other Study ID Numbers: 1K23RR018471 ( U.S. NIH Grant/Contract )
First Submitted: February 19, 2008
First Posted: February 28, 2008
Last Update Posted: February 28, 2008
Last Verified: May 2007

Additional relevant MeSH terms:
Nicotine
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