NCT00625794

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
Last Updated

February 28, 2008

Status Verified

May 1, 2007

Enrollment Period

1.7 years

First QC Date

February 19, 2008

Last Update Submit

February 27, 2008

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.

    12 weeks

Secondary Outcomes (1)

  • Acceptability of the Nicotine Nasal Spray by Adolescents.

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

8 weeks or counseling plus 6 weeks of nicotine nasal spray

Drug: Nicotine nasal spray

2

ACTIVE COMPARATOR

8 weeks or counseling only.

Behavioral: Smoking cessation counseling

Interventions

Nicotine nasal sprayDRUG

8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).

1
Smoking cessation counselingBEHAVIORAL

8 weeks or counseling

2

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mark Rubinstein, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

September 1, 2005

Primary Completion

May 1, 2007

Study Completion

July 1, 2007

Last Updated

February 28, 2008

Record last verified: 2007-05

Locations

US(1)