Conditions: Smoking
Keywords: nicotine replacement therapy smoking cessation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6009
Healthy volunteers: no

Brief summary:
20% of Ontarians smoke. There was a decline in smoking prevalence from 1995 but it has remained unchanged since 2002. This rate of smoking cessation has not kept up with the rest of Canada. A new strategy is necessary to increase the number of smokers making quit attempts and to increase the odds of quitting long term.The goal of this study is to evaluate the methods and effectiveness of providing nicotine replacement (NRT) to Ontario smokers. The study will develop an evidence-based protocol for providing NRT, provide faculty development on combining pharmacotherapy with behavioural interventions and will provide an evaluation framework to inform future coverage models.

Detailed description:
According to the US Surgeon General's Report (1988), there are immediate, intermediate and long-term benefits to health from quitting smoking. For example, there is a 50% reduction in coronary heart disease risk in 12 months and the risk of a stroke is reduced to that of a nonsmoker 5-15 years after quitting. (US Surgeon General's Report, 1990, p.vi). In a systematic assessment of the value of clinical preventive services recommended by the US Preventive Services Task Force, smoking cessation treatment for adults was one of the highest-ranked services in terms of its cost effectiveness and its potential to reduce the burden of disease. Most smoking cessation interventions cost less per year of life saved than most widely accepted medical practices. For example, cost-effectiveness analysis of the implementation of the Agency for Healthcare Research and Quality (AHRQ) guidelines show costs of $4,113 per life-year saved, in 2001 prices compared to annual mammography for women aged 40 to 49 years, which costs $71,751 in 2001 prices, and hypertension screening for men aged 40 years, which costs $27,117 in 2001 prices. Therefore, smoking cessation services have been referred to as the "gold standard" for comparing the cost effectiveness of other healthcare interventions. Although some studies have shown high costs from increased healthcare utilization in the first year after quitting smoking due to illness (Martinson, 2003), most studies demonstrate that smokers who quit eventually have significantly lower healthcare utilization than continuing smokers (Fishman, 2003; Warner, 2003) Thus, for healthcare organizations such as the Ontario Health Insurance Plan, implementing smoking cessation services will likely result in a relatively quick return on investment. Both the intensity and duration of behavioural interventions are associated with sustained remission in smoking. The addition of pharmacotherapy doubles the odds of quitting successfully. However, many smokers face barriers in accessing pharmacotherapy. The provision of free pharmacotherapy has the potential to help a substantial number of smokers to quit. A study by Curry et al, 1998, evaluated smokers who were willing to sign up for a cessation-support program under various degrees of coverage for either the program or nicotine replacement therapy (NRT). 10% of Smokers with full coverage were likely to attempt to quit as opposed to 2.5% with partial coverage. Therefore, the USHHS guidelines call for the coverage of these medications. Research has shown that coverage for tobacco dependence treatments can enhance not only the rate of quit attempts but also long-term abstinence for smokers (Levy \& Friend, 2002; Schauffler, McMenamin, Olson, Boyce-Smith, Rideout, \& Kamil, 2001). On average, the odds ratio of quitting at one year was 1.6 for those given free NRT. Therefore, some insurers, both public and private, reimburse patients for stop smoking medications. However, a study by Boyle et al 2002, found that simply including the medication in an insurance plan did not increase quit rates or utilization of medications. Adequate precautions must be taken to ensure that free pharmacotherapy is distributed in conjunction with behavioural interventions to be successful and to be used by those smokers most likely to benefit from pharmacotherapy.Pharmacotherapy can be very expensive if provided to all smokers. However, not all smokers want to quit or require medications to quit (McDonald, 2003). Most smokers use about 2-3 weeks of pharmacotherapy when not combined with behavioural interventions (Pierce, 2002). About 0.05% of smokers looking to quit will seek specialized care. Moreover, if we assume that 70% of current tobacco users (Approximately 1.6 million) in Ontario will try to quit in a given year and that 10% ( i.e. 169,000) of these individuals would qualify for and seek reimbursement for 10 weeks of therapy at $30/week, then the total estimated cost will be about $50 million! This is clearly not fundable and therefore a comprehensive strategy combined with some rational use of pharmacotherapy is necessary.Hypothesis:

The provision of free NRT will increase long-term quit rates (\>/= 6 months) in Ontario smokers.

Arms:
arm 1: Nicotine Replacement Therapy plus Behavioural Intervention

Interventions: intervention 1: Nicotine Replacement Therapy intervention 2: behavioural intervention
Intervention descriptions: intervention 1: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge intervention 2: Smoking cessation counselling, relapse prevention strategies

Protocol document:
Prot_000.pdf: 
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Operations Manual/Study 
Protocol 
 
 
 
 
 
STOP: Stop Smoking Therapy for Ontario Patients 
 
        
 
 
 
 
Operations Manual and Protocol for Study Personnel 
 
Study Sponsor 
Ministry of Health and Long-term Care 
And 
Pfizer Consumer Health Care 
 
 
 
 
 
Centre for Addiction and Mental Health 
33 Russell Street  Toronto, ON M5S 2S1 
 
 
Principal Investigator 
 
 
 
 
Scientist 
Peter Selby, MBBS 
 
 
 
 
Laurie, Zawertailo, Ph.D. 
(416) 535-8501 ext 6859 (office) 
 
 
 
(416) 535-8501 ext 6007(office) 
(416) 260.4170 (fax) 
 
 
 
 
(416) 595-6618 (fax) 
peter_selby@camh.net 
 
 
 
 
laurie_zawertailo@camh.net 
 
Project Coordinator 
 
 
 
 
Research Assistant 
Rosa Dragonetti, MSc 
 
 
 
 
Janet Ho, B.A. 
(416) 535-8501 ext 6343 (office) 
 
 
 
(416) 535-8501 ext 6702(office) 
(416) 260.4170 (fax) 
 
 
 
 
(416) 260.4170 (fax) 
rosa_dragonetti@camh.net 
 
 
 
janet_ho@camh.net 
 
Research Analyst 
 
 
 
 
Project Secretary 
Virginia Ittig-Deland 
 
 
 
 
Janey Haggart 
(416) 535-8501 ext 6762 (office)  
 
 
 
(416) 535-8501 ext 4455 (office) 
 
 
 
(416) 260.4170 (fax) 
 
 
 
 
(416) 260.4170 (fax) 
 
 
virgina_ittig-delan@camh.net 
 
 
 
janey_haggard@camh.net 


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Table of Contents 
 
Study Preamble……………………………………………………………………………………………….. 
3 
Study Site Information………………………………………………………………………………………… 
4 
Description of NRT……………………………………………………………………………………………. 
4 
Ordering, Tracking, packaging, preparation, dispensing 
 
Ordering………………………………………………………………………………………………. 
 
Tracking………………………………………………………………………………………………. 
 
Dispensing……………………………………………………………………………………………. 
 
4 
5 
5 
Storage 
6 
Recruitment 
 
Recruitment…………………………………………………………………………………………… 
 
Initial Eligibility………………………………………………………………………………………... 
 
Screening……………………………………………………………………………………………… 
 
Inclusion/exclusion Criteria………………………………………………………………………….. 
 
Screening/enrollment………………………………………………………………………………… 
 
7 
7 
7 
7 
8 
Data Collection and Enrollment 
 
Consent Procedure…………………………………………………………………………………... 
 
Enrollment…………………………………………………………………………………………….. 
 
Initial Assessment……………………………………………………………………………………. 
 
Lab Tests……………………………………………………………………………………………… 
 
Specimen Packaging Guidelines…………………………………………………………………… 
 
Carbon Monoxide…………………………………………………………………………………….. 
 
Follow up appointments……………………………………………………………………………... 
 
Self-selection…………………………………………………………………………………………. 
 
8 
9 
9 
9 
9 
10 
10 
11 
Treatment Protocol Deviations and Violations……………………………………………………………… 
11 
Study Duration…………………………………………………………………………………………………. 
12 
Confidentiality………………………………………………………………………………………………….. 
12 
Dealing with Impaired Participants…………………………………………………………………………... 
13 
Hospitalization/Incarceration…………………………………………………………………………………. 
13 
Non-pharmacological Treatment…………………………………………………………………………….. 
13 
Training for Research Staff…………………………………………………………………………………… 
13 
Adverse Event Recording…………………………………………………………………………………….. 
13 
Reporting Occurrences/Incidents……………………………………………………………………………. 
14 
List of Study Forms and Attachments…………………………………………………………….……….… 
15 
Individual Study Models Protocols 
NRT-only Model………………………………………………………………………………………. 
 
Treatment-as-Usual Model………………………………………………………………………….. 
 
Counsellor Model…………………………………………………………………………………….. 
 
Pharmacy Model……………………………………………………………………………………… 
 
Physician Model……………………………………………………………………………………… 
Nurse Model………………………………………………………………………………………….. 
 
17 
18 
20 
22 
24 
26 
Appendices…………………………………………………………………………………………………….. 
27 
Attachments……………………………………………………………………………………………………. 
28 


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Study Preamble 
The purpose of this STOP Study Operations is to provide each model with the information 
necessary for the uniform implementation of the clinical intervention and the standardized 
collection of outcome data, and, in so doing, ensure consistency in keeping with ethical standards of 
research.   
 
The CAMH models for STOP discussed in this manual include: 
o Treatment-as-Usual Model 
o Pharmacy Model 
o NRT-only Model 
o Physician Model 
o Nurse Model – to be determined 
o Counsellor Model 


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Study sites information 
Centre for Addiction and Mental Health 
The STOP Study includes several sites across the province. This Operations Manual is specific 
to the models to be run out of the Nicotine Dependence Clinic (NDC) at CAMH. Participants 
recruited to the study will be seen at the NDC- Russell Street Site. 
 
Description of NRT 
The nicotine replacement therapies that are used in this study include the Nicoderm patch (21, 14 
and 7mg doses), the Nicorette gum (2 and 4mg) and the Nicorette inhaler. See package insert for 
a complete description of the products (Attachment 5). 
 
Ordering, tracking, packaging, preparation, dispensing  
 
Ordering Initial shipments 
NRT will be ordered through the contact at Pfizer: Bill Carroll (905-968-2510) 
The RA and Pharmacist (Eva) will order a supply of NRT on a monthly basis from Pfizer 
warehouse using the NRT Order Form-Pfizer (Appendix R). The NRT will be stored in the 
pharmacy storage in the basement. 
 
Ordering additional NRT 
The Research Assistant will track NRT stock for all treatment models and will plan to reorder 
additional supply of NRT 4 weeks prior to depletion of stock. The Research Assistant will 
consult with Pharmacy staff (Eva) before ordering next shipment to ensure that space is available 
for next shipment. The RA will use an NRT Order Form-Pfizer (Appendix R) to order 
additional supply of medication.  
 
Treatment-as-Usual Model 
Ss will get their NRT from the ARF Pharmacy as per usual practice. Pharmacy will use 
STOP NRT only for Ss subjects. During Wednesday evening clinic, the NDC nurse will 
dispense the NRT. The RA and NDC nurse will meet weekly to order additional NRT 
using the NRT Internal Order Form (Appendix S). The subjects in this model will be 
provided with only 10-weeks of one form of NRT from the STOP Study. Any additional 
NRT that a subject may use is to be prescribed or purchased outside of the realm of the 
study and be recorded as a concomitant medication on the Concomitant Medications 
Record (Appendix U).  
 
NRT-only Model 
The RA will order a supply of NRT on a weekly basis from Pharmacy using the NRT 
Internal Order Form (Appendix S). The NRT will be stored in a locked cabinet in the 
RA’s office. Only the RA and Scientist will have access to this cabinet. 
 
Pharmacy Model 
The Pharmacy will use STOP NRT stock for Ss. Pharmacy will track the amount of NRT 
dispensed using their internal database. 
 


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Counsellor and Physician Models 
The RA will order a supply of NRT on a weekly basis from Pharmacy using the NRT 
Internal Order Form (Appendix S)  
 
 
Tracking: Keeping inventory/dispensation records of NRT 
 
A Drug Shipment Record (Appendix T) will document: 
1. Medication (indicate patch, gum, or inhaler) 
2. Date received 
3. Expiry date and lot number 
4. Strength  
5. Quantity 
 
A Drug Administration/Subject Record Log (Appendix M) will be used to track the NRT 
dispensed to Ss. The log will identify: 
1. Subject ID 
2. Study # 
3. Date dispensed 
4. Dose 
5. Type of NRT: include lot number 
6. Dispensed by 
 
A Concomitant Medications Record (Appendix U) will be created for each participant. The 
record will be stored in each subject’s chart and will identify: 
1. Medication (patch, gum, inhaler) This section is meant for drugs other than actual study 
drug and should capture all medications taken by the subject at the onset and duration of 
the study. 
2. Dose 
3. Frequency 
4. Indication 
5. Start date 
6. Stop date 
 
Dispensing the NRT 
Dispensation of the NRT for the study shall be in accordance with the CAMH Delegation of 
Dispensing Policy (Attachment 4). 
 
Ss will receive a total of 10 weeks of NRT. Research staff will dispense type and dose of NRT 
based on approved use of the medication and will not provide off-label use. If subjects want to 
use a combination of NRT or increase their dose or NRT, they may do so by purchasing 
additional NRT at their local pharmacy. This data/information should be collected and recorded 
in each Ss chart. Additional use of NRT will be recorded as a Protocol Violation (see page 11).  
 
 
 


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Dispensing by Research Assistant 
The RA will be trained in dispensing NRT by CAMH Pharmacy staff and will store and dispense 
for several models of the study including the NRT-only model, the Physician Model and the 
Counsellor Model. The RA will also serve as back-up for other models when usual staff are 
unavailable. The RA will complete a Medication Used in Research Studies Dispensation 
Form (available from Pharmacy). This form will be kept in the Pharmacy with a copy in the 
Research Binder. The RA will maintain records of each dose dispensed using the Drug 
Administration Subject Record (Appendix M). NRT used by the RA will be kept in a locked 
cabinet in a locked room.  
 
For the NRT-only Model: The RA will take Ss into a designated office, which will 
display the NRT on shelves. Ss will take their recommended NRT and the RA will stamp 
their NRT Card.  
 
Dispensing by Pharmacy 
Pharmacy will maintain control records of dispensing of the research NRT. Pharmacy will use 
the Drug Administration Subject Record (Appendix M) to track the dispensed NRT. Pharmacy 
will dispense to the following models: 
 Pharmacy Model 
 NDC Treatment as Usual Model: Physicians will prepare the prescription using the STOP 
Prescription Form (Appendix Q) for the NRT and Ss will take the prescription to the 
Pharmacy. Pharmacy will dispense as per usual practice for CAMH clients. However, 
Pharmacy will track the NRT dispensed using the above forms. 
 
Dispensing by Nurse 
The RNs will track the NRT dispensed using the Drug Administration Subject Record 
(Appendix M). Nurses will dispense the NRT for the following models: 
 Nurse Model: The Study Nurse will dispense the NRT according to the NRT Algorithm 
(Appendix N).  
 NDC Treatment as Usual Model: The NDC Nurse will dispense NRT for the clinic on 
Wednesday evening (4:00 – 7:00 p.m.). 
 
Any additional NRT prescribed by the NDC physician will be paid for by the subject/client and 
will not be provided from STOP NRT stock. Any NRT that is given to Ss in addition to their 10-
weeks should be recorded as protocol violations (See Section on Protocol Violation page 11).   
 
Storage 
The NRT shipped to CAMH will be stored in Pharmacy’s Storage area (in the basement of the 
East wing of 33 Russell Street site). Pharmacy will track the NRT supply and the RA will have a 
copy of the tracking forms. The RA will complete an internal NRT Internal Order Form 
(Appendix S) to stock local supplies (i.e., supply for different models in NDC). Local supplies of 
NRT will be kept in a locked cabinet in a locked room in the Nicotine Dependence Clinic.  A 
limited number of individuals will be have access to this cabinet and these individuals will be 
specified in writing on the Signature and Delegation of Authority Log (Appendix V). 
 


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Returned/Unused NRT 
Some study subjects may choose to return their unused, unopened packages of NRT. This may 
happen if the subject has quit and no longer feels the need to use NRT. Subjects should be 
informed that they may want to taper off slowly before stopping the NRT completely to assess 
whether they may experience withdrawal once again.  
 
If subjects do not wish to continue their NRT, you may accept their unused packages. These 
packages should be returned to the CAMH pharmacy to be disposed of according to appropriate 
procedures. Staff should document the amount, type, dose and lot number of the NRT that is 
being returned before giving it to the pharmacy.  
 
Subjects may also keep their unused NRT and should be advised to consult with their physician 
or pharmacist if they wish to restart the NRT at a later date. 
 
DO NOT reuse the returned the NRT for other study subjects. 
 
Recruitment, Enrollment 
 
Recruitment 
Study Subjects (Ss) will be recruited through various methods. CAMH programs will refer their 
clients who are interested in quitting smoking to the study. Advertisements and posters will be 
distributed internally at CAMH to make CAMH internal programs and staff aware of the study. 
 
Advertisements will also be placed in local media to recruit Ss. Additional recruitment strategies 
will be employed based on recruitment rates. All recruitment methods will be pre-approved by 
REB. 
 
Initial Eligibility Determination: All participants entering treatment at this site or who respond 
to advertisements will call the research staff for an initial telephone screening. A Telephone 
Screening Form (Appendix A) will be used to assess eligibility.  
 
Those potential participants failing initial screening: All screening forms of participants 
failing initial screening will be kept in the back section of the “Screening Binder” and filed by 
alphabetical order of last name. Each time a participant agrees to be screened for the study, this 
binder must be checked to ensure he/she has not been previously screened.  A new screening 
form can be completed and the old screening form should then indicate that he/she was re-
screened and the outcome of the re-screening. 
 
Those meeting initial screening: If a potential subject indicates interest in participating in the 
study and meets the initial screening, a copy of the screening form is placed in front section of 
the “Screening Binder”. Research staff will use the Triage Form (Appendix B) to help subjects 
choose the study model. The research staff will then set up an appointment with the Research 
Assistant (approximately 70 minutes) for the participant to sign the Consent Form (Appendix C) 
and complete the Initial Study Assessment (Appendix D). Other appointments (depending on 
study model) will be set up at this time as well.  
 


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If a potential participant is not currently in treatment and fails initial eligibility or is no longer 
interested in the study, he/she will be provided with a list of providers to contact for possible 
treatment as well as other resources that are available for smoking cessation. 
 
Screening 
Research staff will screen potential participants using the following criteria: 
 
Inclusion Criteria 
 Age: 18 years or older 
 Ontario residents  
 Current daily smoker 
 Smokes > 10 cigarettes/day 
 Smoked more than 100 cigarettes in their lifetime 
 Wants to quit within next 30 days 
 
Exclusion Criteria 
 Have a medical condition that would make participation medically hazardous as determined 
by the Study Physician (e.g., recent cardiovascular incident) 
 Intolerant to NRT 
 Have an acute severe psychiatric condition in need of immediate treatment or be an imminent 
risk to self or others. These subjects will be referred to a hospital emergency or the ER at the 
Clarke Site. 
 
Subject Screening/Enrollment Log 
Research staff will track screening on the Subject Screening/Enrollment Log (Appendix E). 
The items to be recorded include subject initials, screen date, meets criteria (yes/no), date of 
enrollment into study, date declined and rationale. This form is to be kept in the Research 
Binder. 
 
Data Collection Procedures 
 
Consent Procedures: 
Consent forms (Appendix C) will be filed in the Research Binder. All versions will be kept in 
the binder and the most recent version will be filed in front of other versions. All versions of 
consent forms will also be stored on the T-drive. A Consent Versions Tracking form 
(Appendix F) found in the Research Binder will also track versions of the consent form. 
 
a) The research staff will escort the participant to a private office and begin the consent process.   
b) All participants will first be given a copy of the consent form and asked to follow along on 
her copy as the consent form is read to him/her.   Prior to reading, research staff will give a 
general overview of the study.  The potential participant will also be encouraged to ask 
questions about any part she does not understand as the consent form is read to her. 
c) In order to further facilitate questions, at the end of each page, and in natural breaks in the 
consent form section, research staff will ask if the participant has any questions.  The 
participant will also be reminded that he/she may ask questions at any time during the 
consent process.  


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d) Following reading of the consent form, the research staff member will ask the participant if 
he/she wants to participate in the study.  If she does, the participant and research staff 
member will sign and date all copies of the consent.   
e) The research staff and the study subject will initial each page of the consent form to 
document review of that page.  
f) Person obtaining consent will document process and outcome, noting time of signature in the 
source documents.  
g) The subject will be given a copy of the signed consent form to take home. 
h) Genetics Sub-study: If Ss wish to participate in the genetics sub-study, they will provide their 
consent by checking off this box in the Agreement to Participate section of the study consent 
from and initialing it. If they consent to this sub-study, they will be administered additional 
questionnaires and DNA information will be collected from their blood sample. 
 
Enrollment  
After consent has been obtained, the research staff will assign a Participant Study Code to the 
initial assessment form. Research Staff will maintain a master list of the Participant Study Codes 
and the names of clients in the Master Subject Study Codes (Appendix G). This master list will 
be stored on a non-networked computer and password protected. 
 
Initial Assessment Appointment 
The research staff will administer the Initial Study Assessment (Appendix D) Participants will 
not self-administer the questionnaires. The approximate time needed to complete the form is 45 
minutes.  
 
Determining eligibility according to major health concerns 
The Study Physician will review the medical information on each assessment on a weekly basis 
to determine if subjects that have special medical issues or concerns should be excluded from 
participating in the study.  
 
Genetics Study 
For Ss that consented to participate in the genetics component of the study, they will also be 
administered the M.I.N.I. (Mini-International Neuropsychiatric Interview – Attachment 1). This 
will take an additional 15 to 20 minutes.  
 
Lab tests 
Upon completion of the consent process and the Initial Study Assessment, research staff will 
collect blood samples from the Ss. A second sample of blood will be taken at Week 6 of the 
study. These biological samples will be used to determine plasma concentrations of nicotine and 
the main metabolites cotinine and 3-hydroxycotinine. 
 
Blood:  
Purpose: 
1. For genotyping if study subject consents 
2. For initial plasma cotinine 
Only qualified research staff who have received a certificate in venipuncture procedures will 
collect a blood sample from Ss.  


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Procedure for Venipuncture and Blood Handling: 
Refer to the LN.E.1 Venipuncture Procedure – (Attachment 2). 
 
Specimen Packaging Guidelines 
To ensure patient confidentiality all specimens are to be packaged as follows: 
 All containers (e.g. blood tubes) must be checked for cracks before filling and only intact 
containers used. 
 Check that the caps and lids on all containers are secure before packaging. 
 Place each specimen in a brown paper bag and close the bag. 
 
Requisitions are placed in the brown paper bag with the specimen(s).  
 
Place a label containing the proper address on the brown paper bag. 
 
Tracking laboratory specimens 
All specimens collected will be tracked using the Laboratory Specimen Tracking/Shipping 
Log (Appendix H). The research staff will fill in the visit number, date shipped, shipping # and 
frozen/ambient. The Laboratory Specimen Tracking/Shipping Log will be kept in the 
Research Binder. 
 
Carbon Monoxide: Research staff will use a carbon monoxide monitor to measure CO levels in 
participants.  
 
The interviewer will tell the participant the following: 
“I am now going to measure the level of carbon monoxide present in your body. This is going to 
serve as a baseline measure of your exposure to CO. CO is produced in your body in small 
amounts, but it is also a by-product of smoking.” 
 
Procedure: 
1. 
Research staff trained by the Laboratory or RN of the Nicotine Dependence Clinic 
may perform this procedure. 
2. 
Turn the Smokerlyzer on using the ON/OFF switch (a short beep will be heard). 
3. 
Insert the Sampling Assembly into the Sensor Housing on the Smokerlyzer. 
4. 
Fit a Disposable Cardboard Mouthpiece into the clear end of the Sampling Assembly. 
5. 
As long as the Smokerlyzer registers less than 5 ppm CO, press the ‘Zero’ button 
until ‘GO’ is displayed. 
6. 
Ask the participant to inhale deeply and hold their breath.  At the same time press the 
‘GO’ button on the Smokerlyzer which will begin a 15-second count down until 
testing time. 
7. 
Hand the Smokerlyzer to the participant. 
8. 
Near the end of the 15-second count down the Smokerlyzer will beep several times 
ending with one long beep indicating that it is time for the participant to exhale into 
the cardboard mouthpiece. 
9. 
When the display reads 0, have the participant exhale gently and steadily (until their 
lungs are emptied) into the mouthpiece making sure that a tight seal is made by the 
lips around the mouthpiece. 
10. 
Record the date and breath CO reading (in ppm) on the initial assessment form.   


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11. 
Remove the Cardboard Mouthpiece from the Sampling Assembly and discard it.  
12. 
To reuse press “go” again, then “zero” again and repeat the test from step 9. 
13. 
Wait until the Smokerlyzer registers less than 5 ppm before performing another test. 
14. 
Should problems arise during the testing process (error message “Err” or “Neg” 
appearing on the display) please contact the RN of the Nicotine Dependency 
Programs or the Laboratory for assistance. 
 
6-week follow up appointment 
Ss will be asked to come in to complete the 6-week Follow Up Interview (Appendix I) and to 
provide a blood sample.  As informed consent is ongoing, determine and document that the Ss is 
willing to continue as a study participant. Carbon monoxide levels will also be collected. 
 
 
End-of-treatment assessment 
Ss will be asked to come in to complete the End-of-treatment assessment (Appendix J). Carbon 
monoxide levels will also be collected. 
 
Follow up assessments 3, 6, 12 months 
Ss will be asked to complete a follow up assessment at 3, 6 and 12 months post-treatment. The 
Research staff will contact the Ss by telephone and arrange a time to complete the interview 
using the follow up assessments (Appendix K). A sub-sample of Ss will be asked to come in to 
provide a blood sample.  
 
Self-selection 
 
During the initial assessment, Ss who qualify for participation in the study will be administered 
the Triage Form (Appendix B) to help determine which model they wish to join. The models 
available for subjects include: 
 
NRT-only Model: Subjects receive 10 weeks of NRT approximately every two weeks and get 
no additional support or interventions. Refer to Page 17 for detailed procedures. 
 
Treatment as Usual Model: Subjects receive 10 weeks of NRT. They are registered as CAMH 
clients and complete the General Assessment. They attend the Nicotine Dependence Clinic and 
discuss a treatment plan with their health care provider. Refer to Page 18 detailed procedures. 
 
Counsellor Model: Subjects receive 10 weeks of NRT. They are scheduled to see a counselor in 
the Nicotine Dependence Clinic for three brief counseling sessions. Refer to Page 20 for detailed 
procedures. 
 
Pharmacist Model: Subjects receive 10 weeks of NRT. They are scheduled to see a Pharmacist 
in the ARF Pharmacy for three brief counseling sessions. Refer to Page 22 for detailed 
procedures. 
 


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Physician Model: Subjects receive 10 weeks of NRT. They are scheduled to see a Physician in 
the Nicotine Dependence Clinic for three brief counseling sessions. Refer to Page 24 for detailed 
procedures. 
 
Nurse Model: Subjects receive 10 weeks of NRT. They are scheduled to see a Nurse in the 
Nicotine Dependence Clinic for three brief counseling sessions. Refer to Page 26 for detailed 
procedures. 
 
Treatment Protocol Deviations and Violations 
Protocol Deviations and violations are terms used interchangeably and refer to the same thing. 
Briefly, a protocol deviation or violation is any procedure that was not completed in the way or 
at the time or in the sequence that it was supposed to according to the protocol.  
 
If a protocol violation occurs, the clinician or clinic staff will alert the RA. The RA will record 
the violation in the subjects chart and inform the Scientist. The Scientist will provide a weekly 
report to the REB and/or Research Office informing them of protocol violations. If it becomes 
apparent that a part of the protocol is being violated on a regular basis, then the study team will 
discuss possible solutions and will apply to the REB for an amendment to the protocol that will 
reflect these changes. 
 
Study Duration 
Study participants will have access to 10 weeks of NRT. Clients will be asked to complete 
follow up questionnaires at 6 weeks, end-of-treatment and at 3 months, 6 months and 12 months. 
The follow up assessments will be conducted via the telephone. However, a sub-set of study 
subjects will be scheduled to come in to provide blood samples. Once participants have 
completed their 10-week supply of NRT, they will be advised of treatment options/programs in 
their community. 
 
Premature Termination or Withdrawal 
Subjects may experience adverse events due to the transdermal nicotine replacement therapy. 
The most serious adverse reaction associated with transdermal nicotine replacement therapy is 
localized itching at the site of application. If this occurs, Ss will be advised that this reaction is 
not serious and can be treated with aloe/lotion or cortisone-based cream as recommended by 
their family physicians or Study Physician. If subjects are not able to tolerate the reaction, they 
may voluntarily withdraw from the study at any time and for any reason. Ss may also switch to 
another form of NRT after consultation with the Study Scientist. 
 
Missed Appointments 
Ss may miss up to three appointments. Clinicians may call the Ss after each missed appointment 
to reschedule. Each time the clinician calls, the Ss should be informed they will have a limited 
number of rebookings before they are dropped from the study. Clinicians should use the 
following script as a guideline when making the phone calls. 
 
Hi (name of subject). This is (name of clinician) from the STOP study. You missed your 
appointment today. Are you still interested in participating in the study?  


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If no: Ask Ss why?? – should we do this or should Janet just follow up? 
If yes: I would like to reschedule your appointment. However, I should inform you that you may 
not miss more than 3 appointments before you are excluded from the study. Are you available…. 
 
Confidentiality 
Study participants will be assigned a Participant Code and subject initials to protect 
confidentiality. Since a component of the study involves assessing health card utilization 
following study participation, the participants will provide their OHIP numbers. Research staff 
will maintain a confidential, password-protected database that links the participant code to the 
OHIP numbers. 
 
Protecting data: Data will be stored in computerized files that are not networked and will be 
password-protected. Hard copies will also be kept in locked filing cabinets in the research staff’s 
office in the Nicotine Dependence Clinic. 
 
Transferring data: A diskette and/or CD will be used to transfer the data. E-mail will be used to 
transfer anonymous data only where applicable and appropriate. Data transfer will occur between 
any of the investigators, study staff or study sites.  
 
At the end of the study, all data will be entered into a common anonymized computerized 
database. All paper records will be anonymized and stored for 10 years. The Principal 
Investigator and delegates will have access to the data. 
 
Dealing with Impaired Participants 
Study staff will refer impaired clients to the Addiction Medicine Clinic if subjects are seriously 
impaired. The appointment will be rescheduled. 
 
Hospitalization/Incarceration During Study Duration 
Subjects who are incarcerated during the study will be withdrawn. Subject hospitalized during 
the study will be reassessed for participation. If no interruption occurs to their study protocol, 
they may remain in the study.  
 
Non-pharmacological Treatment 
Ss may be referred to other treatment programs if they want additional treatment such as 
individual counseling or group counseling. If Ss are interested in accessing services of the 
Nicotine Dependence Clinic, Ss will be referred to the Assessment Department to complete a 
CAMH general assessment and to register as a CAMH client. Clients who want other referrals 
will be given a list of available resources in their community.  
 
Training for Research Staff 
Research staff will attend training to use the CO Monitor, centrifuge equipment and venipuncture 
procedures. CO monitor training will be provided by the RN in the Nicotine Dependence Clinic. 
Venipuncture training will be provided by CAMH. Centrifuge training will be provided by the 
NDC nurse.  
 
Adverse Event Recording 


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Adverse Drug Reaction (ADR): any noxious and unintended response to a drug that is caused 
by the administration of any dose of the drug. 
 
Serious Adverse Drug Reaction: Adverse drug reaction that requires in-patient hospitalization 
or prolongation of existing hospitalization, that causes congenital malformation, that results in 
persistent or significant disability or incapacity, that is life-threatening or that results in death. 
 
Serious Unexpected Adverse Drug Reaction: Serious adverse drug reaction that is not 
identified in nature, severity or frequency in the risk information set out in the investigator’s 
brochure or on the label of the drug. These events are subject to expedited reporting to Health 
Canada under the marketed drugs AE notice.  
 
Adverse Event: Adverse occurrence in the health of a clinical trial subject who is administered a 
drug that may or may not be caused by the administration of the drug, and includes adverse drug 
reaction. 
 
Adverse Events will be reported to the Principal Investigator and Scientist immediately and will 
be tracked using the Adverse Events Tracking From (Appendix W) found in the Research 
Binder. The staff person collecting the information about the adverse event from the Ss will use 
the Adverse Events Form (Appendix X) which will be found in every Ss files.  
 
Reporting Occurrences/Incidents 
CAMH Occurrence/Incident Reports: Research staff will complete the online 
Occurrence/Incident Report form for all incidents. Incident reports are filled in whenever a 
CAMH staff member is injured in any way or there is a near miss. These reports are required by 
law. 
 
Occurrences are defined as: An unexpected occurrence involving the death or serious physical 
or psychological injury or risk thereof (near miss). Injury does not have to have occurred. The 
potential for injury and/or property damage (financial loss) is sufficient for an occurrence to be 
considered an incident. 
 
A Sentinel event most often identifies a rare, adverse or potentially avoidable occurrence that 
has the potential to result in: 
 Significant threat to patients, residents, employees, volunteers or visitors 
 Imminent litigation 
 Significant financial loss 
 Significant damage to the reputation of the corporation. 
 
Refer to the following link for CAMH’s policy on Occurrence/Incident Reports. 
http://insite.camh.net/policies/policies/pc_1_15_1_occurrence_incident_reporting_sentinel_event
.pdf 
 


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If you are unsure whether an incident or occurrence is reportable, please follow up with the 
Project Manager and/or Scientist. The following link will direct you to the online forms.
 
https://home.camh.net/incidentreport/create.php 
 


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Study Forms 
A. 
Telephone Screening Form 
B. 
Triage Form 
C. 
Consent Form 
D. 
Initial Study Assessment 
E. 
Subject Screening Enrollment Log 
F. 
Consent Versions Tracking Form 
G. 
Master Subject Study Codes 
H. 
Laboratory Specimen Tracking/Shipping Logs 
I. 
6-week follow up assessment 
J. 
End-of-treatment Assessment 
K. 
3-month, 6-month, 12-month follow up assessment 
L. 
Voucher Card 
M. 
Drug Administration Subject Record 
N. 
NRT Algorithm 
O. 
Stop Study Medication Profile 
P. 
STOP Progress Note 
Q. 
STOP Prescription 
R. 
NRT Order Form-Pfizer 
S. 
NRT Internal Order Form 
T. 
Drug Shipment Record 
U. 
Concomitant Medications Record 
V. 
Signature and Delegation of Authority Log  
W. 
Adverse Events Tracking Form 
X. 
Adverse Events Form 
Y. 
Suspect Adverse Reaction Report 
Z. 
Pharmacy Card  
AA. 
Quality Control Form 
BB. 
Running Balance Inventory 
 
Attachments 
1. M.I.N.I. 
2. LN.E.1 Venipuncture Procedure 
3. STOP Brief Intervention Form 
4. CAMH Delegation of Dispensing Policy 
5. NRT Package Inserts 
6. Cessation Resource List 
 
 


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Individual Study Models Protocols 
 
 
 
NRT-only Model 
 
Treatment-as-usual Model 
 
Counsellor Model 
 
Pharmacist Model 
 
Physician Model 
 
Nurse Model 
 


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NRT-only Model 
 
The NRT only model will resemble a convenience store model. Ss will be able to walk into a 
venue whereby NRT is displayed and Ss are permitted to choose the type and dose of NRT they 
wish to use. However, Ss will be instructed that they may only use one type of NRT at a time and 
the dose must be in compliance with package guidelines (i.e., no off-label use).  No additional 
support will be provided in this model to emulate the experience of purchasing NRT in a 
convenience store. Ss are permitted to seek additional support on their own outside of the study. 
Such data will be recorded in the Ss file. 
 
Recruitment 
Ss will be recruited according to STOP Operations Manual procedures. The RA will use the 
Triage Form (Appendix B to help subjects choose a model. Ss who are interested in receiving 
NRT only with no additional support may choose this model.  
 
Dispensing 
Upon completion of the initial assessment, the research staff will give Ss a Voucher Card 
(Appendix L) to use to obtain their NRT from the study. Ss will attend the clinic bi-weekly (or as 
convenient), present their vouchers to the Research staff and choose the NRT for the next two 
weeks. Subjects may choose the type of NRT they prefer and the dose they feel is appropriate. 
However, they will only receive a total of 10 weeks of treatment.  
 
Ss will be able to pick up their NRT during the following hours: Mondays 9:00 a.m. to 5:00 p.m., 
Tuesdays 9:00 a.m. to 5:00 p.m., Wednesdays 12:00 p.m. to 7:00 p.m., Thursdays 9:00 a.m. to 
5:00 p.m. and Fridays 9:00 a.m. to 5:00 p.m. 
 
Storage 
Research staff will stock NRT in a locked cabinet in a research office in the Nicotine 
Dependence Clinic and will keep track of the stock using the appropriate tracking forms Drug 
Administration Subject Record (Appendix M). The Ss will visit an office where NRT is 
stocked similar to a Convenience store (on shelves).  
 
Termination 
The RA will schedule an appointment to complete the 10-week follow up appointment or end-of-
treatment assessment. All Ss will be given a list of resources (Attachment 6) for additional 
support in quitting smoking. If Ss wish to attend the Nicotine Dependence Clinic at CAMH, they 
should be referred to general assessment to register as a CAMH client and complete a general 
assessment.  


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Treatment-as-Usual Model Protocol 
 
Subjects who wish to access the Nicotine Dependence Clinic at CAMH will be referred to this 
model. Subjects must register as CAMH clients and receive a Health Record Number to 
participate in this model.  
 
Recruitment 
Ss will complete their general addiction assessment and nicotine assessment with the CAMH 
clinical staff. Nicotine Clinical staff will inform clients about the STOP study. If clients are 
interested, clinicians will contact the STOP research staff provide the client health record number 
and phone number.  
 
Alternatively, Ss will be recruited via advertisements. Ss will call the RA to qualify for the study. 
The RA will use the Triage Form (Appendix B) to help subjects choose a model. Ss who wish to 
participate in this model will be referred to a Counsellor for a CAMH general assessment. They 
will also be given an appointment with an NDC Physician for a medical appointment.  
 
Dispensing NRT 
 
Dispensing and Tracking 
Dispensation of the NRT shall be in accordance with the CAMH Delegation of Dispensing 
Policy (Attachment 3).  Ss will receive a total of 10 weeks of NRT. Research staff will dispense 
type and dose of NRT based on approved use of the medication and will not provide off-label 
use. If Ss are prescribed combination of NRT or dosing above approved indications, they may 
purchase the additional NRT. This data/information should be collected and recorded in each Ss 
chart. Additional use of NRT will be recorded as a Protocol Violation (see page 11). Ss may 
apply for an NDC subsidy if they cannot afford to pay for additional NRT prescribed by the 
NDC Physician. Ss may be referred to an NDC clinician to complete a subsidy form. 
 
Dispensing by Pharmacy 
Pharmacy will maintain control records of dispensing of the research NRT. Pharmacy will use 
the Drug Administration Subject Record (Appendix M) to track the dispensed NRT. 
Physicians will prepare the prescription using the STOP Prescription Form (Appendix Q) for 
the NRT and Ss will take the prescription to the Pharmacy. Pharmacy will dispense as per usual 
practice for CAMH clients. However, Pharmacy will track the NRT dispensed using the above 
forms. 
 
Concomitant Medications 
Pharmacists will use the STOP Study Medication Profile (Appendix O) form to record other 
medications used by the Ss during their participation in the study. This also includes any 
additional NRT purchased by the subject. This form is used by pharmacists as part of treatment-
as-usual. Pharmacists see clients immediately following a nicotine assessment to review 
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Treatment Plan 
A treament plan will be developed by the clinician for the client as per usual standard of practice 
of the Nicotine Dependence Clinic. The research staff will contact the client before their 
physician appointment to have client sign consent form and collect blood samples and complete 
the Initial Assessment. Clients will attend treatment as usual. Research staff will contact clients 
at 6 weeks to complete 6-week Follow Up Interview (Appendix K) and collect a final blood 
sample. Clinical staff will use the STOP Progress Note (Appendix P) to record visits with the 
subjects. Ss will be seen bi-weekly. Physicians will use the STOP Prescription Form (Appendix 
Q) to prepare prescriptions for these Ss. They may prescribe combination NRT or off-label 
prescribing as this is the protocol used in NDC. However, STOP will only provide 10 weeks of 
one type of NRT. Additional NRT dispensed will be recorded in the charts and recorded as 
Protocol Violations (Page 11).  
 
Payment for medication 
Ss may apply for an NDC bursary to help pay for the additional NRT they are prescribed. Ss 
should be referred to NDC clinicians to apply for a bursary. 
 
Termination 
The RA will schedule an appointment to complete the 10-week follow up appointment or end-of-
treatment assessment. Ss who require additional support may continue to attend the clinic and 
access treatment. 


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Counsellor Model 
 
The Counsellor Model will offer Ss brief interventions for smoking cessation based on the US 
Department of Public Health and Human Services Guidelines. The Ss will attend 3 sessions with 
a trained smoking cessation counselor. The counselor will follow the STOP Brief Interventions 
Protocol (Attachment 3). 
 
The Study counselor will have received an orientation training to brief interventions and to the 
Study Protocol. In addition to procedures outlined in this section, the Counsellor will be familiar 
with all components of this Operations Manual. Any questions about the study procedures should 
be directed to the Project Scientist or the Project Manager. 
 
Research staff will complete the initial assessment with the Ss. Ss will then be referred to the 
Counsellor to discuss a plan. The Counsellor will provide counseling according to the STOP 
Brief Interventions Protocol (Attachment 3). Ss will return at 6-weeks for a follow-up including 
providing blood/urine sample and CO. Subjects will come in for their initial assessment, one 
week post-quit date, six weeks after initial assessment and at end-of-treatment (10 weeks). 
 
Recruitment 
Ss will be recruited according to STOP Operations Manual procedures. The RA will use the 
Triage Form to help subjects choose a model. Ss who wish to see a Counsellor for brief 
interventions will be referred to this model.  
 
Dispensing NRT 
 
Dispensing and Tracking 
Dispensation of the NRT shall be in accordance with the CAMH Delegation of Dispensing 
Policy (Attachment 4).  The RA will dispense the NRT and will track the NRT dispensed by 
completing a Drug Administration Subject Record (Appendix M). Study Subject charts will be 
kept in the RA’s office. 
 
Concomitant Medications 
The RA will collect this information at time of initial assessment and at each follow up 
appointment. 
 
Brief Treatment Protocol 
Please see the Brief Intervention Protocol (Attachment 3) attached for complete details. Ss will 
be seen by the RA for an initial assessment and referred to the Counsellor if they choose the 
Counsellor Model. The Counsellor will see the Ss according to the schedule below: 
 
Visit #1: 
During this first visit, the Counsellor will help Ss determine the type and dose of NRT using the 
STOP NRT Algorithm (Appendix N).  The Ss can change the type of NRT or dose if they 
choose. The Counsellor will record all changes to NRT using the Progress Note (Appendix P). 
During this visit, the Counsellor will also record other medications the Ss are taking using the 


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STOP Study Medication Profile (Appendix O). The Counsellor will use the Brief Intervention 
Protocol (Attachment 3) to collect relevant data and provide brief counseling.  Ss will be asked 
to set a quit date during this visit and they will be given their NRT. The amount of NRT will 
depend on when they have set their quit date (i.e. enough NRT to last until second visit). 
However, the Counsellor will attempt to limit the NRT dispenses at this time to two weeks to 
encourage Ss to set a quit date within that time. 
 
Visit #2:  
The second visit will occur within one to two weeks of their quit date. Staff can follow the 
treatment protocol and collect appropriate data. During this session, staff will schedule a third 
and final visit. Staff will also schedule approximately ½ hour with the RA. To do this, please call 
Janey Haggart at 4455 or Janet Ho at 6702 and ask to book a 6-week follow-up assessment. 
 
Visit #3:  
The third visit will be scheduled for 6 weeks after the Ss start NRT. Ss will be given the 
remaining 4 weeks of NRT. If Ss require ongoing support, they may be referred to other 
resources.  
 
Termination 
The RA will schedule an appointment to complete the 10-week follow up appointment or end-of-
treatment assessment. All Ss will be given a list of resources (Attachment 6) for additional 
support in quitting smoking. If Ss wish to attend the Nicotine Dependence Clinic at CAMH, they 
should be referred to general assessment to register as a CAMH client and complete a general 
assessment.  
 
Study Forms relevant to this Model 
Brief Intervention Protocol (Attachment 3) 
Cigarette Withdrawal Scale 
Appointment Calendar 
NRT Algorithm (Appendix N) 
Pharmacy card (Appendix Z) 
Drug Administration Subject Record (Appendix M) 
STOP Progress Note (Appendix P) 
STOP Medication Profile (Appendix O) 
Adverse Events Form (Appendix N) 
Smoking Cessation Resource List (Attachment 6) 


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Pharmacy Model Protocol 
 
The Pharmacy Model will offer Ss brief interventions for smoking cessation based on the US 
Department of Public Health and Human Services Guidelines. The Ss will attend 3 sessions with 
one of three ARF Pharmacists. The Pharmacists will follow the STOP Brief Interventions 
Protocol (Attachment 3). 
 
Pharmacy staff have received an orientation training to brief interventions and to the Study 
Protocol. In addition to procedures outlined in this section, Pharmacists will be familiar with all 
components of this Operations Manual. Any questions about the study procedures should be 
directed to the Project Scientist or the Project Manager. 
 
Research staff will complete the initial assessment with the Ss. Ss will then be referred to the 
ARF Pharmacy (make a 15 – 30 minute appointment with Pharmacy staff) to discuss a plan with 
the pharmacist. Pharmacy staff will provide counseling according to the STOP Brief 
Interventions Protocol (Attachment 3) to the Ss.  
 
Ss will be informed they can schedule appointments with the pharmacist during the following 
hours:  
Mondays  
9:00 a.m. to 3:30 p.m. 
Tuesdays  
9:00 a.m. to 11:30 a.m. 
Wednesdays  9:00 a.m. to 3:30 p.m. 
Thursdays  
9:00 a.m. to 11:30 p.m. 
 
Recruitment 
Ss will be recruited according to STOP Operations Manual procedures. The RA will use the 
Triage Form to help subjects choose a model. Ss who wish to see a Pharmacist for brief 
interventions will be referred to this model.  
 
Dispensing NRT 
 
Dispensing and Tracking 
Dispensation of the NRT shall be in accordance with the CAMH Delegation of Dispensing 
Policy (Attachment 4).  The pharmacist will dispense the NRT during the hours listed above. Ss 
will be given a Pharmacy Card (Appendix 2) which they are to present at each visit so that the 
Pharmacist may record the information on the card. The information includes visit number, type 
and dose of NRT.  Pharmacy staff will track the NRT dispensed using the database already 
employed by the ARF Pharmacy. They will also complete a Drug Administration Subject Record 
(Appendix M) Study Subject charts will be kept in the Pharmacy area in a locked folder provided 
by STOP and will be returned to Janet Ho when the subject completes 10 weeks. 
 
Concomitant Medications 
Pharmacy staff will use the STOP Study Medication Profile (Appendix O) form to record other 
medications used by the Ss during their participation in the study. This also includes any 
additional NRT purchased by the subject. 
 


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Brief Treatment Protocol 
Please see the Brief Intervention Protocol (Attachment 3) attached for complete details. Ss will 
be seen by the RA for an initial assessment and referred to Pharmacy if they choose the 
Pharmacy Model. Pharmacy will see the Ss according to the schedule below: 
 
Visit #1: 
During this first visit, the Pharmacist will help Ss determine the type and dose of NRT using the 
STOP NRT Algorithm (Appendix N).  The dose and type of NRT will be recorded on the 
Pharmacy Card. The Ss can change the type of NRT or dose if they choose. Pharmacy will 
record all changes to NRT using the Progress Note (Appendix P). During this visit, Pharmacists 
will also record other medications the Ss are taking using the STOP Study Medication Profile 
(Appendix O). Pharmacists will use the Brief Intervention Protocol (Attachment 3)to collect 
relevant data and provide brief counseling.  Ss will be asked to set a quit date during this visit 
and they will be given their NRT. The amount of NRT will depend on when they have set their 
quit date (i.e. enough NRT to last until second visit). However, Pharmacists will attempt to limit 
the NRT dispenses at this time to two weeks to encourage Ss to set a quit date within that time. 
 
Visit #2:  
The second visit will occur within one to two weeks of their quit date. Staff can follow the 
treatment protocol and collect appropriate data. During this session, staff will schedule a third 
and final visit. Staff will also schedule approximately ½ hour with the RA. To do this, please call 
Janey Haggart at 4455 or Janet Ho at 6702 and ask to book a 6-week follow-up assessment. 
 
Visit #3:  
The third visit will be scheduled for 6 weeks after the Ss start NRT. Ss will be given the 
remaining 4 weeks of NRT. If Ss require ongoing support, they may be referred to other 
resources.  
 
Termination 
The RA will schedule an appointment to complete the 10-week follow up appointment or end-of-
treatment assessment. All Ss will be given a list of resources (Attachment 6) for additional 
support in quitting smoking. If Ss wish to attend the Nicotine Dependence Clinic at CAMH, they 
should be referred to general assessment to register as a CAMH client and complete a general 
assessment.  
 
Study Forms relevant to this Model 
Brief Intervention Protocol (Attachment 3) 
Cigarette Withdrawal Scale 
Appointment Calendar 
NRT Algorithm (Appendix N) 
Pharmacy card (Appendix Z) 
Drug Administration Subject Record (Appendix M) 
STOP Progress Note (Appendix P) 
STOP Medication Profile (Appendix O) 
Adverse Events Form (Appendix N) 
Smoking Cessation Resource List (Attachment 6) 
 


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Physician Model Protocol 
 
The Physician Model will offer Ss brief interventions for smoking cessation based on the US 
Department of Public Health and Human Services Guidelines. The Ss will attend 3 sessions with 
the Study Physician. The SP will follow the STOP Brief Interventions Protocol (Attachment 3). 
 
The SP will have received an orientation training to brief interventions and to the Study Protocol. 
In addition to procedures outlined in this section, the SP will be familiar with all components of 
this Operations Manual. Any questions about the study procedures should be directed to the 
Project Scientist or the Project Manager. 
 
Research staff will complete the initial assessment with the Ss. Ss will then be referred to the SP 
to discuss a plan. The SP will provide counseling according to the STOP Brief Interventions 
Protocol (Attachment 3). Ss will return at 6-weeks for a follow-up including providing 
blood/urine sample and CO. Subjects will come in for their initial assessment, one week post-
quit date, six weeks after initial assessment and at end-of-treatment (10 weeks). 
 
The Study Physician (SP) will see study subjects (Ss) during a designated clinic in NDC.  
 
Recruitment 
Ss will be recruited according to STOP Operations Manual procedures. The RA will use the 
Triage Form to help subjects choose a model. Ss who wish to see a Physician for brief 
interventions will be referred to this model.  
 
Dispensing NRT 
 
Dispensing and Tracking 
Dispensation of NRT shall be in accordance with the CAMH Delegation of Dispensing Policy 
(Attachment 4).  The RA will dispense and track the NRT dispensed by completing a Drug 
Administration Subject Record (Appendix M). Study Subject charts will be kept in the RA’s 
office. 
 
Concomitant Medications 
The RA will collect this information at time of initial assessment and at each follow up 
appointment. 
 
Brief Treatment Protocol 
Please see the Brief Intervention Protocol (Attachment 3) attached for complete details. Ss will 
be seen by the RA for an initial assessment and referred to the Physician if they choose the 
Physician Model. The Counsellor will see the Ss according to the schedule below: 
 
Visit #1: 
During this first visit, the SP will help Ss determine the type and dose of NRT using the STOP 
NRT Algorithm (Appendix N).  The Ss can change the type of NRT or dose if they choose. The 
SP will record all changes to NRT using the Progress Note (Appendix P). During this visit, the 


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Counsellor will also record other medications the Ss are taking using the STOP Study 
Medication Profile (Appendix O). The SP will use the Brief Intervention Protocol (Attachment 
3) to collect relevant data and provide brief counseling.  Ss will be asked to set a quit date during 
this visit and they will be given their NRT. The amount of NRT will depend on when they have 
set their quit date (i.e. enough NRT to last until second visit). However, the SP will attempt to 
limit the NRT dispenses at this time to two weeks to encourage Ss to set a quit date within that 
time. 
 
Visit #2:  
The second visit will occur within one to two weeks of their quit date. Staff can follow the 
treatment protocol and collect appropriate data. During this session, staff will schedule a third 
and final visit. Staff will also schedule approximately ½ hour with the RA. To do this, please call 
Janey Haggart at 4455 or Janet Ho at 6702 and ask to book a 6-week follow-up assessment. 
 
Visit #3:  
The third visit will be scheduled for 6 weeks after the Ss start NRT. Ss will be given the 
remaining 4 weeks of NRT. If Ss require ongoing support, they may be referred to other 
resources.  
 
Termination 
The RA will schedule an appointment to complete the 10-week follow up appointment or end-of-
treatment assessment. All Ss will be given a list of resources (Attachment 6) for additional 
support in quitting smoking. If Ss wish to attend the Nicotine Dependence Clinic at CAMH, they 
should be referred to general assessment to register as a CAMH client and complete a general 
assessment.  
 
Study Forms relevant to this Model 
Brief Intervention Protocol (Attachment 3) 
Cigarette Withdrawal Scale 
Appointment Calendar 
NRT Algorithm (Appendix N) 
Pharmacy card (Appendix Z) 
Drug Administration Subject Record (Appendix M) 
STOP Progress Note (Appendix P) 
STOP Medication Profile (Appendix O) 
Adverse Events Form (Appendix N) 
Smoking Cessation Resource List (Attachment 6) 
 


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Nurse Model Protocol 
 
Currently, there is no Nurse Model. Future consideration will be given to this model. 
 


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Appendices 
 
 
A. 
Telephone Screening Form 
B. 
Triage Form 
C. 
Consent Form 
D. 
Initial Study Assessment 
E. 
Subject Screening Enrollment Log 
F. 
Consent Versions Tracking Form 
G. 
Master Subject Study Codes 
H. 
Laboratory Specimen Tracking/Shipping Logs 
I. 
6-week follow up assessment 
J. 
End-of-treatment Assessment 
K. 
3-month, 6-month, 12-month follow up assessment 
L. 
Voucher Card 
M. 
Drug Administration Subject Record 
N. 
NRT Algorithm 
O. 
Stop Study Medication Profile 
P. 
STOP Progress Note 
Q. 
STOP Prescription 
R. 
NRT Order Form-Pfizer 
S. 
NRT Internal Order Form 
T. 
Drug Shipment Record 
U. 
Concomitant Medications Record 
V. 
Signature and Delegation of Authority Log  
W. 
Adverse Events Tracking Form 
X. 
Adverse Events Form 
Y. 
Suspect Adverse Reaction Report 
Z. 
Pharmacy Card  
AA. 
Quality Control Form 
BB. 
Running Balance Inventory 
 
 


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Attachments 
 
1. M.I.N.I. 
2. LN.E.1 Venipuncture Procedure 
3. STOP Brief Intervention Form 
Cigarette Withdrawal Scale 
Appointment Calendar 
4. CAMH Delegation of Dispensing Policy 
5. NRT Package Inserts 
6. Cessation Resource List