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Nicotine Replacement and Counseling In Adolescents

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00625794
First received: February 19, 2008
Last updated: February 27, 2008
Last verified: May 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acceptability of the Nicotine Nasal Spray by Adolescents. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mark Rubinstein, MD, UCSF
ClinicalTrials.gov Identifier: NCT00625794     History of Changes
Other Study ID Numbers: 1K23 RR18471, 1K23 RR18471
Study First Received: February 19, 2008
Last Updated: February 27, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013