Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01679236 |
| Other study ID # |
H-2006-0279 |
| Secondary ID |
P50DA019706-09 |
| Status |
Completed |
| Phase |
Phase 0
|
| First received |
August 31, 2012 |
| Last updated |
May 19, 2014 |
| Start date |
September 2006 |
| Est. completion date |
September 2009 |
Study information
| Verified date |
May 2014 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
A. The study follows a randomized controlled design with approximately 60 smokers with a
history of alcohol abuse age 18-29. The study will compare a 7-week mindfulness intervention
to a matched 7-week education intervention to evaluate intervention effect on smoking
cessation and reduction in alcohol use. The primary hypothesis is that the mindfulness
intervention will yield statistically significantly higher smoking abstinence than controls
as measured by carbon monoxide breath test and Time Line Follow Back at at the end of
treatment (2-weeks post smoking cessation attempt).
Description:
B. The study follows a randomized controlled study design with division of approximately 60
individuals into 2 groups. The study group (n=30) will be called "Mindfulness Training for
Smokers" (MTS) and will provide 7 weeks of mindfulness meditation instruction. The control
group (n=30) will be called the "Interactive Learning for Smokers" (ILS) will provide 7
weeks of addiction instruction. Classes in both groups will be 2 hours long. At meeting 5,
the "quit day," all participants will attempt to quit smoking permanently and attempt to
quit using alcohol for 4 weeks.
Mindfulness Training For Smokers (MTS) Course Outline is as following:
Meeting 1 Introduction. Meditation training: posture, breath counting, mindful recognition
of thoughts. Mindfulness meditation: physical sensation, emotion. Philosophical orientation:
addiction, meditation. Meeting 2 Mindful monitoring: craving curve, withdrawal symptoms
(agitation, anxiousness, anger, anhedonia, confusion, hunger, defeatist thoughts). Meeting 3
Education: tobacco and alcohol disorders. Motivational information. Meeting 4 Practical
strategies: tobacco and alcohol cessation. Meeting 5 QUIT DAY, Individual-work and
group-work focusing on thoughts, cravings, and withdrawal symptoms occurring in individuals
that day. Meeting 6 Individual and group discussion of progress. Review: mindfulness,
thoughts, emotions, physical sensations, drug cues, triggers. Meeting 7 Discussion of
long-term meditation practices and risks.
Daily Mindfulness Meditation: All participants will be asked to meditate 30 minutes per day
for 7 weeks.
Control Group Intervention (ILS) The control intervention is designed to be a time matched
effective treatment for tobacco and alcohol addiction. The treatment is an interactive
"class" in addiction including 7 meetings (matched to study subjects). Controls will be
asked to engage in daily "non-directed walking" 30 minutes per day and not smoking when they
walk. In addition, controls (as study group participants) will be provided with other
practical strategies for smoking cessation taken from the American Lung Association, Freedom
from Smoking program and The Mayo Clinic Nicotine Dependence Center program.
Quit day: The quit day for controls as well as study subjects will be at meeting-5 (same as
for study group). For study subjects, this day will be held in silence and will include 5
hours of various meditation practices, including a silent bag lunch. For controls, this day
will include a 5-hour study session in a punctuated by several non-directed walks. All class
time activities and quit day activities will be conducted as a group. MTS and ILS study
participants will attempt smoking cessation at midnight the night before meeting five.
Participants will be told to collect and destroy all of their alcohol, cigarettes, and
tobacco-related paraphernalia beforehand. During the meeting on the "quit day" participants
will perform CO testing to confirm abstinence. A secondary goal of the intervention is
alcohol reduction for the purpose of reducing risk for smoking relapse. Because long term
complete abstinence from alcohol is an unnecessary and perhaps unrealistic, goal for most
non-dependent drinkers, the goal for all participants is alcohol abstinence for 4 weeks.
Description of Sample: Participants will consist of 60 subjects age 18-25. There will be an
effort to include gender and ethnicity with distribution seen in the Madison population.
C. Recruitment: Recruitment will be conducted through placement of recruitment flyers
throughout the UW-Madison, MATC, and Edgewood campuses as well as the greater Madison area.
Recruitment will also use recruitment flyer in electronic form to advertise and through
Craig's List and newspaper ads. These will all use identical format as is used in the flyer.
For each of these mediums, an electronic version of the recruitment flyer will be posted.
Recruitment will also included one-minute presentations to classes by personnel or the
faculty/staff teaching the class. This will entail showing a power point slide with the
electronic recruitment flyer, and may or may not include reading it out loud to students.
This will only occur if the professor of a particular class agrees to this one minute
presentation. Advertisements will state that the intervention is designed to help
participants quit smoking. An effort will also be made to include minority students in a
percentage that reflects university minority enrollment. Respondents will be screened by
phone for the criteria listed below. Those who meet criteria will be scheduled for an
orientation session, which will describe the intervention. Interested individuals will be
offered the consent form, after which, randomization to study group or control group will be
performed via random number generation. Recruitment will continue until 30 controls and 30
group participants (3 cohorts of 10) have been enrolled or until statistical significance
between groups is reached. Subjects will be paid $20 at the quit day, the 2 week post-quit
visit, and $40 at the 8-week and 6-month post-quit visits (total of $120). In addition to a
total of $120 per participant payment, participants who come to all 4 data collection days
will have their name put in a "lottery" drawing for $1000.
Inclusions: 1) Age 18 to 29 years; 2) Tobacco use of at least 10 cigarettes per day for at
least 6 months; and, 3) Alcohol use of 5 or more binges/month (Binge = 5 or more drinks for
a male, 4 or more for a female). Rationale for Inclusions: Tobacco use levels are set to
allow for a broad range of daily tobacco use, while eliminating occasional smokers. Alcohol
use set at this level to include the majority of student smokers (known to drink at this
level) and provide outcomes information on co-treatment of alcohol and tobacco.
Exclusions: 1) A baseline (orientation meeting) CO level < 10, 2) Self report of
pre-existing diagnosis of bipolar disorder, schizophrenia or other delusional disorder; 3)
Self report of pre-existing diagnosis of personality disorder (e.g., borderline, antisocial,
schizoaffective personality disorders). 4) Self report of alcohol use of 4 drinks or more a
night on 6 or more nights per week.
Rationale for Exclusions: Bipolar disorder, Schizophrenia, delusional disorders, and
personality disorders are used as exclusions because of the high potential for individuals
with these disorders to disrupt other participants in therapeutic group session. A CO level
of 10 is required to establish a minimal level of tobacco dependence. High level alcohol use
is an exclusion criterion because these individuals may withdraw from alcohol during alcohol
reduction.
Hypothesis: The primary hypothesis is that the mindfulness intervention will yield
statistically significantly higher smoking abstinence than controls as measured by carbon
monoxide breath test and Time Line Follow Back at at the end of treatment (2-weeks post
smoking cessation attempt).
D. Safety Monitoring Plan This study proposes to obtain information from participants about
their age, race, gender, as well as psychiatric and drug use information. All data from
human subjects in this research protocol will be obtained by interview or questionnaire and
will be obtained specifically for research purposes. Subject names will not be kept on data
records, but instead, a standardized code will be used for identification. Access to these
code numbers will be limited to staff members of the research team. All collected forms will
be stored in locked file cabinets. Patient identifiers will be kept in separate files from
the data forms. All patient identifiers will be destroyed at the end of the trial. No
existing records or data will be utilized. Alcohol Withdrawal: Symptoms of alcohol
withdrawal in clinically dependent drinkers include sweating, nervousness, nausea and
vomiting, headaches, myalgias, tremors, delusions, hallucinations, seizures and death. Heavy
drinkers (4 or more drinks/day) will be excluded from the study to ensure that subjects with
a potential for clinical withdrawal are not in the study. Nonetheless, participants will be
instructed that if symptoms of withdrawal occur, they are to report immediately to the
emergency room for treatment and notify Dr. Davis (PI) of their condition. Dr. Davis is
board certified in Internal Medicine and routinely manages patients in alcohol withdrawal.
