Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00156702 |
| Other study ID # |
VTSF8520012 |
| Secondary ID |
VTSF8520012 |
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
September 8, 2005 |
| Last updated |
January 7, 2013 |
| Start date |
January 2001 |
| Est. completion date |
October 2006 |
Study information
| Verified date |
January 2013 |
| Source |
Virginia Commonwealth University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
The primary hypothesis of this pilot study is that dependence can be prevented in
adolescents who smoke, but who are not yet dependent. With this study, we seek to develop
and test the feasibility and provide controlled comparisons of two brief smoking
dependence-prevention interventions: motivational interviewing with feedback versus a video
control. Forty adolescents between the ages of 12 and 18 will be enrolled. The evaluation
and dependence-prevention phases will occur during a single 3- to 4-hour session, and the
30-45 minute follow-up sessions will take place approximately one month, three months, six
months, and one year after the completion of the evaluation and dependence prevention
phases.
Description:
III. Hypothesis: The primary hypothesis of this pilot study is that dependence can be
prevented in adolescents who smoke, but who are not yet dependent. With this study, we seek
to develop and test the feasibility and provide controlled comparisons of two brief smoking
dependence-prevention interventions. Additional analyses will be conducted to determine
which, if any, demographic, psychological, personality, behavioral, or family
characteristics predict which adolescents respond best to dependence-prevention
interventions, though no clear a priori predictions can be made.
IV. Specific Aims: The primary aim of this pilot study is to prevent dependence in
adolescent smokers, who are at great risk for nicotine dependence and tobacco-related
disease. Nicotine dependence is a disease that begins in children and adolescents:
approximately three quarters of adult tobacco users (i.e., cigarette and cigar smokers and
users of smokeless tobacco, or SLT) report that their first tobacco use occurred when they
were 11-17 years old (USDHHS, 1994a; 1994b; Riley et al., 1996). Moreover, the earlier a
person starts smoking, the higher their eventual daily cigarette consumption (Taoli and
Wydner, 1991), and the greater their risk of dying from a smoking-related disease (USDHHS,
1989). Because smoking begins in adolescents and because young tobacco users are at the
greatest risk for progressing to dependence and dying of smoking-related disease, adolescent
smokers would benefit immensely from effective tobacco dependence prevention.
VI. Preliminary Progress/Data Report: This project involves an evaluation phase, including
laboratory measurement of tobacco's effects, a dependence-prevention phase, and a follow-up
phase. Because the laboratory measurement is critical to the success of all phases (data
generated in the laboratory phase are used in the intervention and thus influence the
follow-up), this preliminary data section will focus on laboratory research.
The Clinical Behavioral Pharmacology Laboratory (CBPL; T. Eissenberg, Director) has been a
site for safe and ethical studies of tobacco use in adults (e.g., Eissenberg et al., 1999;
Buchhalter and Eissenberg, 2000; Buchhalter et al., 2001; Breland et al., in press). In
addition, Dr. Eissenberg initiated a discussion on how to conduct safe and ethical tobacco
research in adolescents: in 2000, he planned and chaired a symposium entitled "Ethical and
Practical Challenges in Tobacco Research with Children" at the 6th Annual Meeting of the
Society for Research on Nicotine and Tobacco (Eissenberg, 2000; see also Eissenberg and
Balster, 2002). He has also been involved in several laboratory studies involving young
adults (e.g., Gire and Eissenberg, 2001) and adolescents (Zack et al., 2001; Corrigall et
al., 2000).
Progress on the current project has included the establishment and maintenance of an
adolescent clinical lab facility for direct observation of young smokers and for testing
brief-intervention strategies in a controlled setting; recruitment of scientific and
clinical staff; development of subject recruitment procedures; engagement of local school
personnel in the recruiting process, utilization of advertising on city buses to aid
recruitment, development and pilot testing of the brief interventions; successful completion
of 17 subject baseline lab sessions and 8 telephone follow-at 1 month, 3 at 3 month, 1 visit
at 6 months, 1 phone contact at 9 month, and 1 visit at 12 month. Four participants have
been lost to follow-up.
VII. Research Method and Design: This pilot protocol includes several integrated components:
recruitment, telephone or in-person screening and Parental Information Sheet and assent, a
psychosocial assessment, a laboratory assessment, two different dependence-prevention
interventions, and a follow-up component. The evaluation and dependence-prevention phases
will occur during a single 3- to 4-hour session, and the 30-45 minute follow-up sessions
will take place approximately one month, three months, six months, and one year after the
completion of the evaluation and dependence prevention phases. Each phase is outlined below.
Recruitment phase. Potential participants will be recruited through print ads, attached to
this protocol for IRB review, some of which may be distributed through schools with school
permission. Along with the ads, each student will receive the parental information and
assent procedures, therefore parents will be informed about the study directly by the
adolescent. The parental information sheet would explain that their teenager is interested
in being part of a study on the prevention of tobacco dependence. It gives a brief
description of the study. Parent signatures indicate they have received the information. For
those adolescents that find out about the study by fliers or word of mouth, the parental
information sheet will be sent by mail. Flyers may also be distributed by willing
adolescents. Interested peers may then call to see if they are eligible, and if they qualify
and come to the baseline phase we will send a referral fee of five dollars to the original
participant for each referral that does so. Even if the original participant receives the
referral fee, the name of the other participant will not be divulged.
Screening, consent, and assent phase. Potential participants will be initially screened
using the screening interview. Screenings might occur via telephone or in person, depending
upon individual preference. The sole purpose of the screening interview is to determine if
interested adolescents meet the study inclusion/exclusion criteria (see below). The
screening interview collects the minimum amount of information needed to determine
eligibility and maintains the potential participant's anonymity. This same information is
collected again (as background data, below) to determine reliability of reporting.
Individuals who are unable to report their own smoking history reliably are ineligible for
further participation.
Following the initial screening process, potential participants will be told that their
parents/legal guardians need to sign and date the parental information and assent
procedures. The parental information and assent procedures will explain that their teenager
is interested in being part of a study looking at the prevention of becoming an addicted
smoker and giving a brief description of the study. Individuals will have as much time as
needed to consider their child's participation. The child will bring the parental signed
form with the to the first laboratory session. If the parent wants they can bring the
adolescent and will still be paid to compensate for their time, however it is not required.
Adolescent assent will be done prior to research collection during the initial study
session. A researcher who has completed VCU's Level I IRB training will read the attached
assent form to the adolescent and answer any questions that individual may have. Individuals
will have as much time as needed to consider their participation. Individuals who are
interested in participating will be asked to sign the assent form indicating that they agree
to participate and understand that they may stop participating at any time.
Psychosocial Assessment. Adolescent participants will be asked to complete demographic,
psychological, personality, behavioral, and family questionnaires. The baseline
questionnaires consist of the Child Depression Inventory (Kovacs, 1982), the Revised
Children's Manifest Anxiety Scale (Reynolds & Richmond, 1978), the Leyton Obsessional
Inventory - Child Version (Berg, Rapoport, & Flament, 1987), Barkley's ADHD Scale (Barkely,
1998), the National Youth Survey of Conduct Scale (Elliot, Huizinga, & Morse, 1988), the
Adolescent Life Events Inventory (Compas, et. al., 1987), the Family Assessment Device
(Epstein, Baldwin, & Bishop, 1983), the Millon Adolescent Personality Inventory (Millon,
Green, & Meagher, 1982), and questions pertaining to body image, substance use, and smoking
behavior and attitudes. Each of the questionnaires was developed specifically for use with
children and/or adolescents, and most have been standardized and widely used in a general
adolescent population. These data will be used to report on participant characteristics and
will be especially useful in identifying factors that predict intervention response. We
recognize that asking personal questions sometimes makes people feel uncomfortable.
Participants will be instructed that is any of the questions are upsetting to them, that
they are to tell the researcher. The researcher will then inform a clinician who will
evaluate the participant and determine and recommend necessary services.
Laboratory Assessment: The laboratory assessment will be virtually identical to that
reported elsewhere (e.g., Corrigall et al., 2001) and will involve an approximately 20
minute rest period, questionnaires related to tobacco withdrawal and tobacco/nicotine
effects, ad lib smoking using a mouthpiece that measures puff topography (e.g., puff volume,
number, duration, etc), and a variety of physiological measures. Only adolescents who have
already been smoking on their own are eligible; therefore, we believe the smoking of a
single cigarette in the lab confers no additional risk. During the rest period, participants
will complete demographic and background information questionnaires. Participants will then
be asked to smoke as they normally would, with no other constraints. Participants will
provide their own cigarette (if they have one) or a cigarette will be provided for them.
Outcome measures, described below, include physiological data (e.g., heart rate, breath
carbon monoxide level, etc), subjective reports of tobacco withdrawal symptoms, and puff
topography. Saliva sample will be taken before and after smoking for later measurement of
salivary nicotine and cotinine (a nicotine metabolite).
Questionnaires: All questionnaires are computerized. Withdrawal-related questionnaires
include the QSU-Brief (Cox et al., 2001) MNWS (Hughes and Hatsukami, 1986). The Fagerstrom
Test for Nicotine Dependence will assess dependence levels (FTND; Heatherton, Kozlowski,
Frecker, & Fagerstrom, 1991). Subjective effects of smoking will also be assessed.
Physiological Measures. Two physiological measures will be monitored continuously: heart
rate (every 20 seconds) and blood pressure (every 3 minutes; Noninvasive Patient Monitor
model 507E, Criticare Systems, Waukesha, WI). Expired CO levels will be measured at
screening and before and after smoking using a BreathCO monitor (Vitalagraph, Lenaxa, KS).
This equipment and these procedures have been used extensively in studies at VCU (e.g.,
Buchhalter et al., 2001; Breland et al., in press). In addition, salivary nicotine and
cotinine will be collected before and after smoking. Participants will be asked to chew a
roll of cotton before placing it into a plastic test tube. The test tubes will be stored in
a freezer at no warmer than -32 degrees.
Topography measures: Puff topography is a sensitive measure of drug self-administration in
cigarette smokers and has been used in previous studies of adolescent smokers (e.g.,
Corrigall et al., 2001). Cigarettes are smoked through a mouthpiece that is connected to a
pressure transducer and inhalation-induced pressure changes are amplified, digitized, and
sampled at a rate of 1000 Hz. Software (Plowshare Technologies, Baltimore, MD) converts
signals to air flow (ml/sec) and integrates this flow data, producing measures of puff
volume, duration, number, and interpuff interval (IPI).
Dependence-Prevention Interventions: After the psychosocial and laboratory components,
participants will take a 20-minute break during which snacks and drinks will be provided.
Participants will be assigned randomly to one of two possible dependence-prevention groups.
The random assignment will occur after the evaluation phase, so as not to bias the
experimenters during data collection. One dependence-prevention group involves a brief
motivational interview that provides general and personalized feedback about the immediate
and long-term consequences of smoking, including feedback about the physiological and
psychological impact of tobacco as measured in the evaluation phase. Motivational
interviewing is a promising intervention in adolescent smokers (Colby, et. al., 1998;
Lawendowski, 1998). The second group will receive brief education-based
dependence-prevention interventions. Research indicates that high proportions of
adolescents, particularly smokers, are unaware of many of the significant smoking-related
health risks, including shortened lifespan and the likelihood of dying a smoking-related
death (Romer & Jamieson, 2000). In addition, perceived health risks predicted motivation to
quit, suggesting that if adolescents are better informed about smoking-related health
problems they may be more motivated to stop smoking (Romer & Jamieson, 2000). The second
group will watch a composite of anti-smoking videos, which includes education regarding the
immediate and long-term effects of smoking and education regarding tobacco companies and
their marketing strategies. All participants will earn a $40 mall gift certificate after the
completion of this phase.
Follow-up phase: Brief telephone follow-up sessions will take place approximately one month,
three months, six months, and nine months after the completion of the dependence-prevention
intervention. The telephone follow-ups will consist of a brief time-line follow-back
questionnaire to assess smoking behavior over the past two weeks. Participants will earn $10
mall gift certificates for completion of these telephone follow-ups that will be mailed to
them after completion of the follow-up session. In addition, short follow-up check-ups will
be performed six months and one year after completion of the dependence-prevention
intervention. During these two follow-up check-ups, participants will again complete the
time-line follow-back questionnaire, in addition to some questions about their current
smoking attitudes. Non-intrusive physiological data will be recorded to validate their
reports. Physiological data collection will consist of obtaining salivary nicotine and
cotinine and expired CO levels, using the procedures described above. Participants will earn
$25 mall gift certificates for completion of each of these follow-up check-up sessions. If
the parent / legal guardian does bring the adolescent in, they will be compensated $30 for
each follow-up check-up sessions.
VIII. Statistical Analysis:
Data Analysis. Data analysis will include:
Descriptive Statistics. Means, standard deviations, ranges, skewness, and kurtosis of all
our measures will be examined to determine outliers and normality in our data. In addition,
correlations will be run on all measures to determine what significant relationships exist
between questionnaire and physiological data.
Inferential Statistics. Regarding data in our evaluation condition, we will examine
relationships between questionnaire data and physiological data. Regarding follow-up data,
we will run two-way mixed ANOVAs to examine the effect of the dependence-prevention
interventions on smoking at follow-ups. In addition, we will run regressions using
questionnaire and physiological data as predictors of smoking behavior at follow-up.
IX. Human Subjects Instructions:
A. Description. A total of 40 adolescent smoking volunteers will be needed to complete this
preliminary research protocol. All sessions will take place in the Clinical Behavioral
Pharmacology Laboratory on the Virginia Commonwealth University's medical campus.
Inclusion/Exclusion Criteria: Participants must be healthy, between the ages of 12 and 18
years of age, and be current smokers (defined as at least one cigarette in the last week,
according to participant self-report). In order to ensure that smokers are not yet
dependent, adolescents who have smoked more than 10 cigarettes per day each day of the last
week will be excluded. Other exclusionary criteria include: history of or current specific
health concerns, including cardiovascular disease, pregnancy or current breast feeding.
C. Recruitment Plan. Participants will be recruited by print advertisements, some of which
may be distributed through local schools. Parental information forms will be distributed or
mailed upon contact with the adolescent. Participants will then call the CBPL and potential
participants will participate in the telephone screening described above. If the participant
is eligible for participation, a qualified laboratory staff member who has completed VCU's
Level One IRB Training will obtain assent from adolescents at the beginning of the initial
session. Potential participants are given the opportunity to ask questions during the assent
process and are afforded all the time they need to make an informed decision. Assent forms
are attached for IRB review.
G. Compensation Plan. Participants will be compensated for their time with mall gift
certificates. All participants who complete the initial session (including the evaluation
and intervention components) will receive a $40 mall gift certificate. Participants will
receive an additional $20 mall gift certificate each telephone follow-up and $50 for each of
the in-person follow-up sessions they attend, with a chance to earn a total of $200 in mall
gift certificates. If the participant completes ALL assessments, they will receive a $20
bonus at the 12M follow-up, thereby earning a total of $220 over the year of participation.
If the parent brings the child, but not required to, they will be compensated for their time
as follows: $60 for the initial session, and $30 for the in person visits, totaling up to.
In addition, participants who recruit other adolescents to participate will earn a $5 gift
certificate for each enrolled participant they referred.
H. Consent issues. Screening: As stated above, potential participants will be initially
screened using the screening interview; screenings might occur via telephone or in person,
depending upon individual preference. The sole purpose of the screening interview is to
determine if interested adolescents meet the study inclusion/exclusion criteria and to
schedule the initial visit. The screening interview collects the minimum amount of
information needed to determine eligibility and this same information is collected again (as
background data, below) to determine reliability of reporting. Individuals who are unable to
report their own smoking history reliably are ineligible for further participation. At the
end of the screening interview, the study procedures are described to potential
participants, who are then asked whether or not they are still interested in participating.
If yes, staff will set up the initial appointment.
Parental Information Sheet: Before any research data are collected, the signed and dated
parental information sheet and assent will be collected. The signed Parental Information
Sheet indicating that the parent has reviewed information about the study is required for
adolescents to participate . Individuals will have as much time as needed to consider their
participation. The Parental Information Sheet will be disseminated at with recruitment
information or can be mailed if the participant calls in about the study.
Adolescent assent: Adolescent assent will be obtained prior to research collection during
the initial study session. A researcher who has completed VCU's Level I IRB training will
read the attached assent form to the adolescent and answer any questions that individual may
have. Individuals will have as much time as needed to consider their participation.
Individuals who are interested in participating will be asked to sign the assent form
indicating that they agree to participate and understand that they may stop participating at
any time.
