Extended Cessation Treatment for Teen Smokers (Nicoteens)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00459953
First received: April 11, 2007
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Drug: cognitive and behavioral skills training, nicoderm CQ
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:
  • prolonged abstinence [ Time Frame: end of treatment, 6mos, 12mos ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relapse [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: September 2006
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: extended treatment
extended cognitive behavioral treatment for smoking cessation
Drug: cognitive and behavioral skills training, nicoderm CQ
all participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. Half of the participants receive an additional 9 sessions of cognitive behavior therapy and half receive brief support
Other Names:
  • CBT
  • nicotine patch
Active Comparator: Brief supportive therapy
participants contacted periodically via telephone for supportive therapy
Drug: cognitive and behavioral skills training, nicoderm CQ
all participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. Half of the participants receive an additional 9 sessions of cognitive behavior therapy and half receive brief support
Other Names:
  • CBT
  • nicotine patch

Detailed Description:

Adolescent smokers (aged 14-18; > 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, we 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 at the beginning of the study

Smoking at least 10 cigarettes per day

At least one quit attempt in previous 6mos

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00459953

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Joel D Killen, PhD Stanford University
  More Information

Publications:
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00459953     History of Changes
Other Study ID Numbers: CA118035, R01CA118035
Study First Received: April 11, 2007
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014