© The Author 2013. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.
All rights reserved. For permissions, please e-mail: XXXXXXXXXX.
doi:10.1093/nt
ntt017
Original investigatiOn
a randomized Clinical trial of the efficacy of extended
smoking Cessation treatment for adolescent smokers
Steffani R. Bailey PhD1, Sarah A. Hagen BA2, Christina J. Jeffery BA2, Christopher T. Ha
ison PhD2,
Seth Ammerman MD3, Susan W. Bryson MA, MS2, Diana T. Killen MS2, Thomas N. Robinson MD3,
Joel D. Killen PhD2
1Department of Family Medicine, Oregon Health & Science University, Portland, OR; 2Stanford Prevention Research Center, Stanford
University School of Medicine, Palo Alto, CA; 3Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA
Co
esponding Author: Steffani R. Bailey, PhD, Department of Family Medicine, Oregon Health & Science University,
3181 SW Sam Jackson Park Road, Mailcode FM, Portland, OR 97239, USA. Telephone: XXXXXXXXXX; Fax: XXXXXXXXXX;
E-mail: XXXXXXXXXX
Received July 24, 2012; accepted January 27, 2013
abstraCt
introduction: Relatively few well-designed smoking cessation studies have been conducted with teen smokers. This study exam-
ined the efficacy of extended cognitive–behavioral treatment in promoting longer term smoking cessation among adolescents.
Methods: Open-label smoking cessation treatment consisted of 10 weeks of school-based, cognitive–behavioral group coun-
seling along with 9 weeks of nicotine replacement (nicotine patch). A total of 141 adolescent smokers in continuation high
schools in the San Francisco Bay Area were randomized to either 9 additional group sessions over a 14-week period (extended
group) or 4 monthly smoking status calls (nonextended group). Intention-to-treat logistic regression analysis was used to assess
the primary outcome of biologically confirmed (ca
on monoxide < 9 ppm) point prevalence abstinence at Week 26 (6-month
follow-up from baseline).
esults: At Week 26 follow-up, the extended treatment group had a significantly higher abstinence rate (21%) than the non-
extended treatment (7%; OR = 4.24, 95% CI: 1.20– XXXXXXXXXXFemales also were more likely to be abstinent at the follow-up than
males (OR = 4.15, 95% CI: 1.17–14.71).
Conclusions: The significantly higher abstinence rate at follow-up for the extended treatment group provides strong support
for continued development of longer term interventions for adolescent smoking cessation.
intrOduCtiOn
Adolescent smoking remains a high priority public health con-
cern. The Department of Health and Human Services (2011)
has retained the goal of reducing adolescent smoking rates in
the Healthy People 2020 initiative. Although smoking rates
in the United States have decreased over the past decade, the
decline in adolescent smoking decelerated sharply after about
2002, and there was no statistically significant change in smok-
ing rates among 12th graders from 2010 to 2011 (Johnston,
O’Malley, Bachman, & Schulenberg, XXXXXXXXXXAbout 19% of
12th graders were cu
ent smokers in 2011, with 10.3% smok-
ing on a daily basis and 4.3% smoking at least half a pack per
day (Johnston et al., XXXXXXXXXXConsidering that more than 80% of
adult smokers begin smoking prior to age of 18, it is imperative
to develop effective smoking cessation programs for adolescent
smokers (Department of Health and Human Services, 1994).
Relatively few well-designed smoking cessation studies
have been conducted with teen smokers. Of the 48 studies
included in a meta-analysis of teen cigarette smoking cessation,
only 19 studies randomized participants to treatment condition
(Sussman, Sun, & Dent, XXXXXXXXXXDespite a significant effect size
for treatment quit rate (9.14%) versus control quit rate (6.24%),
the quit rate for adolescent smokers in a treatment program is
low compared with the quit rates of their adult counterparts.
Overall, higher quit rates were found in programs that included
motivation enhancement, cognitive–behavioral techniques,
and social influences approaches. Also, higher quit rates were
found in school-based clinic and classroom modalities and for
programs consisting of at least five treatment sessions. These
esults are promising, but continued research into innovative
treatments for smoking cessation for adolescents is needed.
Standard smoking cessation interventions generally
include 8–12 treatment sessions. However, developments in
the treatment of alcoholism, cocaine, and opioid dependence
eflect the view that drug addictions are chronic, relapsing
disorders requiring extended therapy and follow-up
(McLellan, Lewis, O’Brien, & Kleber, XXXXXXXXXXConsistent
with this perspective, the authors of a recent Cochrane review
suggested that extended treatment programs for adolescent
Advance Access publication March 4, 2013
nicotine & tobacco research, volume 15, number 10 (October XXXXXXXXXX–1662
1655
extended treatment for adolescent smokers
smokers should be developed and tested (Grimshaw &
Stanton, 2006).
Extended treatment could enable smokers to gain confi-
dence in their ability to resist smoking cues by increasingly
crediting their success to personal ability or efficacy rather
than to elements of the therapeutic situation (Bandura, 1977,
1986). This is achieved by including a skills transfer program
during the maintenance phase whereby therapeutic supports
are withdrawn gradually, allowing sufficient time for smok-
ers to achieve full mastery and high levels of personal efficacy
(Bandura, 1986).
Adult smoking cessation studies have begun to examine the
efficacy of extended smoking cessation therapy. Studies that
have included an extended cognitive–behavioral component
show some promise, with most reporting higher-than-average
quit rates at either the 6-month follow-up (Killen et al., 2006,
2008) or 1-year follow-up (Hall, Humfleet, Reus, Munoz, &
Cullen, XXXXXXXXXXIn a recent study by Hall et al XXXXXXXXXXwith older
adult smokers, extended cognitive–behavioral treatment (CBT)
condition produced high cigarette abstinence rates that were
maintained throughout the 2-year study period and was sig-
nificantly more effective than extended nicotine replacement
therapy (NRT) and no treatment across that period. Hall et al.
suggested that studies on extended treatment for smoking ces-
sation be conducted with other age ranges to determine if their
esults can be replicated. To date, no research studies have
examined the efficacy of extended smoking cessation treatment
in adolescent smokers.
The cu
ent study addresses several important gaps in our
knowledge of effective smoking cessation treatment for adoles-
cent smokers. First, this is the first randomized clinical trial to
examine the effects of extended therapy for adolescent smok-
ers. Second, it is one of the first to combine relapse prevention
skills training with pharmacotherapy for teen smokers. Third,
this is one of the first studies with adolescent smokers to use
igorous analytic methods to examine moderators of treatment
esponse in this population.
MethOds
Participant Recruitment
Adolescent smokers were recruited from 10 continuation high
schools in the San Francisco Bay Area over a period of 3 years.
Recruitment was conducted on a nonrolling basis, with a new
cohort participating each academic school year. Students were
ecruited through
ief classroom presentations and infor-
mational tables set up during the school day. Prior to screen-
ing, students under the age of 18 signed an assent form and
18-year-old students signed a consent form. Potential partici-
pants were screened either in-person or via telephone to obtain
demographic information, smoking quantity, and a
ief medi-
cal history. If the teen was under 18 years of age and passed
the initial screening, a telephone screening was conducted with
the participant’s legal guardian to obtain teen’s medical history
and request parental consent (written or ve
al consent in Year
1; only written consent in Years 2 and 3 due to Institutional
Review Board policy change). Finally, for those that remained
eligible, an at-school screening was conducted to assess cur-
ent drug and alcohol use and to obtain a urine sample to test
for pregnancy from all females.
Eligibility
In order to participate in the study, teens had to meet the fol-
lowing criteria: 14–18 years of age; attending one of the partic-
ipating schools; smoking at least 10 cigarettes/day at the time
of screening; expressed interest in quitting smoking; no cu
ent
use of antidepressants, antipsychotics, benzodiazepines, or the-
ophylline; not cu
ently seeing a psychologist or physician for
major depression, panic disorder, social anxiety, or agorapho-
ia; no cu
ent heavy alcohol or substance use (defined as more
than 3 times per week within the past 2 weeks); not cu
ently
using NRT; no history of diagnosed heart problems including
an i
egular heartbeat or abnormal heart rhythm (excluding a
heart murmur); no uncontrolled high blood pressure; no aller-
gies to adhesive tape; and not cu
ently pregnant or planning
on becoming pregnant. Teens that participated in the program
were compensated for their time with gift cards.
The study was approved by the Stanford University
Administrative Panel on Human Subjects in Medical Research.
Study Design
The trial consisted of 10 weeks of open-label treatment for
all participants, followed by nine additional sessions over
a 14-week period for half of the participants randomized to
extended treatment. Follow-ups were conducted at approxi-
mately 26 weeks (6 months) following the baseline assess-
ment (Week 0). Research intervention staff (all with bachelor’s
degree or higher) were trained and supervised by the project
director who has a PhD in Clinical Psychology and exten-
sive experience in treating nicotine dependence. Computer-
generated randomization to extended treatment was conducted
y the study statistician between Week 1 and Week 2 of the
open-label phase to reduce the likelihood of selection bias.
Randomization was conducted within each school using a
permuted block method (block size = 2) to obtain balance
etween groups. Intervention staff and participants remained
lind to treatment group assignments until the end of open-
label treatment.
Given the results of extended therapy with adult smokers,
we estimated that extended therapy would produce an absti-
nence rate of 25% at the 6-month follow-up. Based on our
previous study with adolescent smokers (Killen et al., 2004),
we expected that about 5%–7% of those who received only
open-label treatment to be abstinent at Week 26 follow-up. As
detailed in Fleiss (1981), with abstinence proportions of 5%
and 25%, a sample size of 70 per group gives a power level of
.85 with alpha set at .05.
Open-Label Treatment
All participants received 10 weeks of group-based CBT and
skills training with a set quit date of 2 weeks after the baseline
assessment. Each session was approximately 50 min. Research
staff aided participants in identifying smoking triggers and
developing effective coping plans for resisting urges in self-
identified, high-risk situations. Topics covered also included
the physiology of nicotine addiction and withdrawal, health
effects of smoking cigarettes, and tobacco advertising targeting
youth. All sessions took place at the respective schools of the
participants. All participants also received 9 weeks of nicotine
patch therapy