Extended Cessation Treatment for Teen Smokers — Nicoteens  

Nicotine Dependence Clinical Trial

Official title: Extended Cessation Treatment for Teen Smokers

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

• NCT number: NCT00459953
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2006
• Completion date: July 2011