Extended Cessation Treatment for Teen Smokers (Nicoteens)

This study has been terminated.
(PI stepping down due to health issues)
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01330069
First received: October 13, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

This study is designed to test the efficacy of an extended smoking cessation program for teen smokers. The investigators 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.


Condition Intervention Phase
Cigarette Smoking
Behavioral: cognitive and behavioral skills training
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Cessation Treatment for Teen Smokers

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • expired-air carbon monoxide confirmed abstinence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Abstinence is defined as a report of no smoking and CO level of less than 9PPM


Secondary Outcome Measures:
  • time to relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    relapse is defined as smoking on 7 consecutive days


Enrollment: 141
Study Start Date: June 2006
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: cognitive and behavioral skills training
    CBT + nicotine patch given during open label (10 weeks); CBT or brief telephone support provided during extended treatment
Detailed Description:

Adolescent smokers (aged 14-18 years; > 10 cigarettes/day) attending continuation high schools in the San Francisco-San Jose Bay Area will serve as the target population for this study. 280 smokers meeting eligibility criteria will be randomized. Our primary goal is to examine the effectiveness of a multi-factor extended treatment strategy in promoting longer-term smoking abstinence. All 280 smokers will receive 10 weeks of open label treatment consisting of nicotine patch therapy and group-based, intensive self-regulatory skills training (ST). Following open label treatment, half (n=140) will receive nine additional group-based ST sessions delivered over a 14 week period. Telephone counseling will also be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=140) will not receive any additional therapy beyond that provided in the open label treatment phase. Abstinence and relapse will be assessed at the end of open label (10 weeks) and extended treatment (24 weeks) and at 52 weeks from the time of study entry. Our primary hypothesis is that smokers randomized to extended treatment will have a higher prolonged abstinence rate (PA) at 52 week follow-up than participants receiving only open label treatment. PA at 52 weeks will be the outcome measure used to evaluate the primary hypothesis and will be defined as a report of non-smoking following an initial 2-week grace period during which any smoking is not counted as a failure and an expired-air carbon monoxide level of <9PPM. Here, failure is defined as either seven consecutive days of smoking or smoking on at least one day on each of two consecutive weeks. Point prevalence abstinence will be examined as a secondary outcome and defined as no smoking, not even a puff, for seven consecutive days prior to assessment and an expired-air carbon monoxide level of <9PPM. With 150 participants per cell, the investigators will have, in general, 80% power at a 2-tailed alpha of .05 to detect a difference in abstinence rates of at least 15% over a large range of success probabilities.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330069

Locations
United States, California
Stanford University
Palo Alto, California, United States, 94304
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Joel D Killen Stanford University
  More Information

Publications:
Responsible Party: Joel D Killen, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01330069     History of Changes
Other Study ID Numbers: SU-09272010-6950, CA118035
Study First Received: October 13, 2010
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014