Research Proposal on:

Effectiveness of Nicotine Replacement Therapy

versus

Counseling for the Development of Smoking

Cessation Program

by Basil Al-Abbasi
INTRODUCTION:

Smoking is one of the greatest causes of illness and premature death in the whole world,
including Saudi Arabia. Tobacco takes an enormous toll on the health of the public as the
cause of 440,000 deaths annually in the United States and 4.8 million deaths worldwide. An
estimated 8.6 million persons in the United States have serious smoking-related illness. The
World Health Organization projects that by the year 2030, the use of tobacco will kill 10
million persons annually – including 7 million in developing countries – which will make
tobacco use the world’s leading cause of preventable death. [1]

BACKGROUND AND LITERATURE REVIEW:

Efforts to stop smoking, or programs developed for smoking cessation has been covered by
so many studies, trials, and researches that have deployed various concepts and
experiments to achieve the best and workable method(s) of smoking cessation and control,
including different approaches.

With smokers becoming aware of all types of health problems caused by tobacco, it is
believed that although nearly half of all smokers at developed countries try to stop every
year, only 2-3% succeed. One reason for the low success is that many quit attempts are
unplanned, so that the most effective cessation aids many not be used. [2]

In evaluating the most successful program or approach that has lead to cessation of
smoking, studies vary in comparing Nicotine Replacement Therapy (NRT), Counseling or
Adapting Guidelines for Health Professionals. In one of the randomized double-blind placebo
and controlled trial titled “Nicotine Patch Therapy for Smoking Cessation combined with
Physician Advises and Nurse Follow-up” concluded that significant smoking cessation can be
achieved using combined intervention including Nursing Counseling Follow-up and Relapse
Prevention. [3]

Other studies investigate the impact of different type of Nicotine Replacement that includes
nicotine gum, nasal spray, or patch. One of which, “How Effective is Nicotine Replacement
Therapy in Helping People to Stop Smoking” resulted in confirming that Nicotine
Replacement efficacy was highly significant (P<0.001) for both gum and patch NRT, and
concluded that Nicotine Replacement therapy could enable about 15% of smokers who seek
help in stopping smoking to give up the habit. [4]

In a similar study conducted on “Medical and Surgical Inpatient Who were Smoking at the
Time of Admission,” they were randomized to receive either usual care (no additional advise
at admission), counseling alone (20-minute intervention with written materials) or receive
Nicotine Replacement Therapy (NRT) plus counseling (counseling intervention with a 6-week
course of NRT). This study (conducted on 247 patients) concluded that abstinence was
higher in the NRT plus counseling group (n=91) than in the counseling alone (n=91) or usual
care (n=92) groups. The difference between the group was significant for validated point
prevalence abstinence at discharge (55%, 43%, 37% respectively, P=0.045) and at 12
months (17%, 6%, 8%, p=0.03). Thus, the NRT given with counseling to hospital inpatient is
an effective routine smoking cessation intervention. [5]

Another spectrum, there have been many studies conducted to explore the various
approaches that involve counseling for smoking cessation. In one of the studies that
evaluated the “Group Behavior Therapy Programs for Smoking Cessation,” the author
concluded that the group therapy is better for helping people to stop smoking than self-help
and other less intensive intervention. The chance of quitting was approximately doubled
(N=4375, relative risk [RR] 1.98 at 95% confidence interval [CI], 1.60 to 2.46). [6]

Another study adopted a “Telephone Counseling for Smoking Cessation” and the result of
which, has also concluded that Proactive Telephone Counseling helps smokers interested in
quitting. The result concluded that the relative risk (RR) for cessation at longest follow-up
was 1.37 at 95% confidence interval (CI) (1.26 to 1.50). [7]

A third study under the conceptual approach has looked at the effectiveness of stage based
interventions, thus to promote cessation. This study looked at behavioral approaches,
which includes the stage-based intervention which largely uses the trans-theoretical model
interventions derived from stages theories of behavior change usually incorporate several
key elements.
It is necessary to identify accurately an individual’s stage of change (or readiness to change),
so that an intervention based on stage specific processes of change can be applied. Stage
of change needs to be reassessed frequently, and the intervention should reflect changes in
the individual’s readiness to change. These elements of the intervention are repeated until
the individual achieves and maintains the change in behavior. In this way, stage based
interventions evolve and adapt in response to the individual’s movement through the stages
of change.
Stage based models propose that interventions that take into account the current stage of the
individual will be more effective and efficient than “one size fits all” interventions. Services
aimed at smoking cessation have made extensive use of the approach.
This study, although was based on studying progression onto different phases/stages of
behavior and change has concluded limited evidence exists for the effectiveness of stage-
based interventions in changing smoking behavior. [8]

Other studies looked at the possibility of having the smoking cessation intervention to be
delivered through the existing health care system by directing the implementation of
guidelines that to be adopted as part of the system operation that involves:

• General Practitioner (GP) opportunistically advising smoker to stop smoking during

mature consultation, during advise on and prescribing effective medication to help
them stop smoking.

• Providing behavioral support (in groups or individually) for smokers wanting help with
stopping thus through a Specialist Smokers Service.

• Behavioral support for hospital patient and pregnant smokers, etc.

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 It is recommended that every health system should provide similar strategies toward smoking
cessation. [9]

Some studies have taken new approach whereby a non-combustible nicotine inhaler was
used as an exposure of smoker case groups versus a placebo for control. This method is
also considered one means for smoking cessation, where it was referred on one of the
studies labeled “Efficacy of Nicotine Inhaler in Smoking Cessation: A Double Placebo
Controlled Trial.”
This study has concluded that the inhaler could be useful for short-term smoking cessation,
with a potential or long-term efficacy, which could be achieved by some conditions. [10]

Some methods have considered the utilization of new pharmaceutical treatments in the study
conducted by HJ Open and Associates of whom has studied the impact of new
pharmaceutical Varenicline, with and without nicotine replacement therapy. As such, this
study has concluded that abstinence from smoking was considered greater and craving,
withdrawal symptoms, and smoking satisfaction were less at the end of treatment with
Varenicline than with transdermal NRT. [11]

VARIABLES:

In conclusion, the variables, or different types of exposures that may be considered

associated/leading to the outcomes anticipated that lead to smoking cessation, the following
could be summarized from the previous review of the literature:

• Nicotine Replacement Therapy

o Nasal Spray

o Chewing Gum

o Patch

• Counseling Smoking
o Advisory Leaflet
Cessation
o Physicians/Professional Advise

o Group behavior Therapy

o Telephone Counseling

• Others
o Use of Non-Combustible Nicotine Inhaler

o Sustained-release (SR) Bupropien

STUDY OBJECTIVES:

To determine if the outcome of smoking cessation is optimally achieved through Nicotine

Replacement Therapy (NRT) or through Counseling or both (NRT and Counseling together).
Accordingly, we are trying to address the following questions:

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 o Does Nicotine Replacement Therapy increases smoking cessation compared
to other cessation intervention alone?

o Does counseling increases smoking cessation compared to other cessation

intervention alone?

o Does Nicotine Replacement Therapy and Counseling together increase

smoking cessation compared to other cessation intervention alone?

Therefore, this study will be testing the following hypotheses:

Null Hypothesis (Ho): There is no impact differences between any approach/method

used/adopted for smoking cessation among smokers, including
Nicotine Replacement Therapy (NRT) or Counseling or Both
(NRT + Counseling)

Therefore: Ho: NRT = Counseling = (NRT + Counseling)

Alternative Theory (H1): There is an impact differences between any of approaches used
for smoking cessation, including Nicotine Replacement Therapy
(NRT) or Counseling or Both (NRT + Counseling)

Therefore: H1: NRT ≠ Counseling ≠ (NRT + Counseling)

METHOD OF INVESTIGATION:

Type of Study:

Since the subjects of whom will be contributing/participating in this study are mainly
smokers of whom will be tested through different approaches for them to quit
smoking. Thus, our study will be a Randomized, Experimental Clinical Trial type
of study. The Case and Control subject will be limited to smokers whom are
matched to defined Population Characteristics and specific Demographic Data
references.

Since the Case and Control will be selected from the same population, that satisfy
the same characteristics for smokers, the control group under this study will be
referred to smokers, of whom will not be exposed to any approach been investigated
to impact on smoking cessation. In addition, they will not be given any means of
placebo, as this will be questioned from the ethical perspectives, though a placebo
control group was reviewed/noted by some articles been reviewed to be included as
part of the study. Ethical Issue could be argued since the habit of smoking could be
quitted without intervention, should this be the case, then a Randomization double-

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 blind trial could be considered for an exposure to the Nicotine Replacement Therapy
application.

Finally, Control groups could also be referred to smokers who quit smoking at their
own discretion/choice.

Population Characteristics:

Error Likely to be
Criteria Reason/Explanation
Eliminated
1. Male Gender Since smoking among females is Systematic Errors – Bias
culturally and socially unacceptable and Confounding
and hence, they will be difficult to
identify
2. Age Group 20 to Thus to match a criteria for rational Random Error – Chance
40 years old choice and equal opportunity for
achieving outcome
3. Health and do not To ensure that diseases or health Random Error – Chance
suffer from any status does not affect decision of +
crucial disease smoking cessation Systematic Error – Bias
4. Smoking ≥ 20 Refer to heavy smoker targeted Random and Systematic
cigarettes a day group Errors

5. Smoking for ≥ 2 Means for confirmed official smoker Random Error – Chance
years from casual smoker
6. Willing to To confirm equal opportunity to Confounding
participate for the benefit from exposure
purpose of quitting
smoking

It is strictly important that a confidence interval along with hypothesis testing will be
applied to eliminate any chances of random error.

Therefore the:

Target Population: Male Smokers living in Riyadh Area

Population Source: Smokers Visiting Smoking Cessation Centers distributed at the

five (5) Administrative Districts of Riyadh (North, South, East, West and Central)

Eligible Population: Those who match the criteria listed above

Participant Population: The data been gathered and analyzed of the participant

Research Design:

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 Since the study focuses around an Experimental Clinical Trial type of study, this
study will tend to have three (3) different types of samples of equal size. Each of
which (group of smokers with different characteristics) will be assigned to be tested
by one of the following exposure which associated to achieve the target (outcome) of
Smoking Cessation. The exposures are:

- Negative Replacement Therapy (NRT) – Administered depending on smoker

condition and medical profession recommendation for doers and schedule.

- Counseling – Administered by an experience psychologist on a pre-established

time table frame.

- NRT and Counseling – Together will be coordinated and administered by both

professionals referred to above.

Each group will be studied and followed in isolation from each other and accordingly
transfer between the three groups will not be permitted and all transactions leading
to findings will be dependent from each other.

Due to the nature of this type of studies (Smoking Cessation), the subjects are
usually studied and followed-up for at least one year period with an evaluation and
analysis conducted at different time intervals to calculate the periodic statistics
concluded for exposure. This follow-up usually carried out over the interval of 2
weeks, one month, three months, six months, and 12 months interval/stage.

This monitors the continuous impact of the exposure in leading to cessation level or
percentage or fluctuating of exposures are compared to conclude the most effective
approach to adopt.

Sampling Selection and Sampling Methods:

- Riyadh is being the targeted Geographical Areas selected for this study.

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 - Sample should be collected equally from five different “Smoking Cessation”
Centers (this directly matched to one of the described criteria) distributed at each
of the Administrative district areas of Riyadh Area.

- Sample Size – The sample size reviewed at articles associated for each type of
Exposure varies from one study to another. Therefore, and since we cannot be
able to confirm the study prevalence at this stage and hence not being able to
calculate expected sample (Refer to Formula), it will be strongly recommended to
request for an assistance of an statistician in this connection.

- Sampling Method – Due to the nature of this study where all Administrative Areas
of Riyadh should be represented among the samples for each type of exposure.
Therefore, the best sampling method is Cluster Sampling where each of the
Administrative Districts of Riyadh defined as cluster and presented as unique for
that area. Within each cluster area, a simple random sample will be applied to
select from each cluster.

Data Collection Methods:

As mentioned above, subjects will be identified from each cluster based on Random
Selection of individuals who match the criteria defined for our population.

It is very important to first identify all sample subjects for each type of exposure
under investigation prior to the commencement of the study. In this regard and
assuming that the sample size for each investigation/exposure will be equivalent to
200 participants each. As such, it is anticipated that a total of 120 participants will be
selected from each cluster (Administrative District Area) thus to contribute 40
participants to each study Exposure.

To Summarize Assumption, please note the following:

 200 Participants each study exposure. Thus Exposure Sample Size = 600
Participants

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  Each study will equally presented by participant from each of the five (5)
Administrative District Areas of Riyadh. Therefore, the Total No. of Participants
selected from each area is 600/5 = 120 Participants of whom will be divided equally
among the three study exposure groups 120/3 = 40 Participants.

From the Data Collection Perspective, this study will be carried out with the
assistance and direct involvement of Professionals including Physicians and
Psychologists. The physician will be involved and responsible in the administration
and monitoring of NRT exposure at the first study reference and at the third study
reference (Exposure to NRT and Counseling). The Psychologist will be involved and
responsible for Counseling part of the Research (either through the 2nd Group
exposed to Counseling only or the 3rd group which will be exposed to Counseling in
addition to NRT).

The details of the study administration and exposure application from the point of
evaluation, intervention, exposure guidelines and frequency will not be discussed at
this stage as part of this study proposal.

Human Resources and Materials:

For the convenience of all participants (sample subjects) and despite the fact that the
study involve these exposure variables under investigation, the sample subjects
involved for each will be involved and participated from their referred Administrative
District Location instead of being asked to join other group at one unique study
location, thus for convenience and to eliminate drop-out incidence caused by the
transfer of subject or being required to adopt strict criteria.

Therefore, it is anticipated that the manpower needed should include:

- Study Coordinator at each of the five (5) Administrative Districts of Riyadh

(Appointed on a full-time basis).

- Physician (1-2) on part-time basis.

- Psychologist (2-4) appointed on a part-time basis.

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Methods of Analysis:

From the Literature review and based on the type of the result that will be recorded
(Discrete Data), the statistical test that determines the association of Exposure
Impact (Three Categories Reference) to achieve outcome (Smoking Cessation) is
best seen in the calculation of Relevant Risk (RR).

Since the outcome is calculated as discrete, therefore Chi-Square Test will be used
as statistical analysis to calculate the sample inference to the population. This will
include calculating the Confidence Interval (CI) as well as the P-Value. Thus, to
eliminate any means of chance type of error.

ETHICAL ISSUES:

Ethical Issue is seen from the point if a control group is used in the administration of
NRT which will be provided in an active and placebo format. Thus Ethical Issue is
addressed if placebo is used on the control group with their impression/expectation
that their contribution/participation will assist them to quit smoking!!

STUDY POSSIBLE LIMITATION:

It is anticipated that the study limitation should be referred or seen to be caused by

the following:

- The Use of Control Group at each Level of Exposure

- The Use of Placebo and How it Will be Administered or Controlled

- Sample Method Based on Clustering Technique

- The Possibility of Study Generalization into other Population Reference or other

Category of Variables

- No Record of Those Who Restarted Smoking after Smoking Cessation (Efficacy

of Program Success)

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Thank you

Basil Al-Abbasi

Dec 25’ 10

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References:

1. S.Schroeder. Tobacco Control in the Wake of the 1998 Master Settlement

Agreement. The New England Journal of Medicine 2004; 350-3: 293

2. D.Moore, et al. Effectiveness and Safety of Nicotine Replacement Therapy

Assisted Reduction to Stop Smoking: Systematic Review and Meta-Analysis.
BMJ 2009;228:b1024

3. R.Hurt, et al. Nicotine Patch Therapy for Smoking Cessation Combined with
Physician Advice and nurse-Follow-Up. JAMA 1994; 271(8): 595-600

4. J.Tang, et al. How Effective is Nicotine Replacement Therapy in Helping

People to Stop Smoking?.BMJ 1994; 308:21

5. A.Molyneux, et al. Clinical Trial Comparing Nicotine Replacement Therapy

(NRT) Plus Brief Counselling, Brief Counselling Alone, and Minimal
Intervention on Smoking Cessation in Hospital Inpatients. Thorax 2003;
58:484-488

6. L.Stead, et al. Group Behaviour Therapy Programmes for Smoking Cessation

(Review). The Cochraine Collaboration 2009; 2

7. L.Stead, et al. Telephone Counselling for Smoking Cessation (Review). The

Cochraine Collaboration 2009; 3

8. R.Riemsma, et al. Systematic Review of the Effectiveness of Stage Based

Interventions to Promote Smoking Cessation.BMJ 2006; 326

9. A.McNeill, et al. Smoking Cessation Guidelines for Health Professionals.

Thorax 2000;55-:987-999

10.N.Schneider, et al. Efficacy of a Nicotine Inhaler in Smoking Cessation: A

Double-Blind, Placebo Controlled Trial. Addiction 1996; 91(9): 1293-1306

11.J.Aubin. Varenicline Versus Transdermal Nicotine Patch for Smoking

Cessation: Results from a Randomised Open-Label Trial. Thorax 2008;63:717-
724

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