NCT00459953

Brief Summary

This study is designed to test the efficacy of an extended smoking cessation program for teen smokers. We hypothesize that teen smokers randomized to extended treatment will have a higher abstinence rate at 52 week follow-up than teen smokers receiving only open label treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

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, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

May 30, 2016

Completed
Last Updated

May 30, 2016

Status Verified

May 1, 2016

Enrollment Period

4.8 years

First QC Date

April 11, 2007

Results QC Date

March 2, 2016

Last Update Submit

May 22, 2016

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

  • Point Prevalence Abstinence

    Point prevalence abstinence is defined as a report of nonsmoking (not even a puff) for 7 consecutive days prior to assessment and an expired-air carbon monoxide level below 9 parts per million (ppm)

    6 months

Study Arms (2)

Extended treatment

EXPERIMENTAL

extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy

Drug: Extended treatment

Control group

NO INTERVENTION

Monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact

Interventions

Extended treatmentDRUG

All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.

Also known as: CBT, nicotine patch
Extended treatment

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 14-18 at the beginning of the study
  • Smoking at least 10 cigarettes per day
  • At least one quit attempt in previous 6mos

You may not qualify if:

  • Current DSM-IV disorder (depression, panic disorder, social anxiety disorder and agoraphobia)
  • Current self report of daily or heavy use (more than three times per week) of any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.)
  • Positive urine pregnancy test
  • Currently on bupropion (Wellbutrin, Wellbutrin SR, Zyban) or other antidepressants, MAOI's, antipsychotics, benzodiazepines
  • Currently on NRT
  • Currently receiving formal treatment for substance abuse problem, depression or anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

  • Bailey SR, Harrison CT, Jeffery CJ, Ammerman S, Bryson SW, Killen DT, Robinson TN, Schatzberg AF, Killen JD. Withdrawal symptoms over time among adolescents in a smoking cessation intervention: do symptoms vary by level of nicotine dependence? Addict Behav. 2009 Dec;34(12):1017-22. doi: 10.1016/j.addbeh.2009.06.014. Epub 2009 Jul 5.

    PMID: 19647373BACKGROUND

  • Bailey SR, Hagen SA, Jeffery CJ, Harrison CT, Ammerman S, Bryson SW, Killen DT, Robinson TN, Killen JD. A randomized clinical trial of the efficacy of extended smoking cessation treatment for adolescent smokers. Nicotine Tob Res. 2013 Oct;15(10):1655-62. doi: 10.1093/ntr/ntt017. Epub 2013 Mar 4.

    PMID: 23460656RESULT

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Joel D Killen
Organization
Stanford University
jkillen@stanford.edu
(650) 723-5895

Study Officials

  • Joel D Killen, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 13, 2007

Study Start

September 1, 2006

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

May 30, 2016

Results First Posted

May 30, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)