Smoking CessationNCT02123329
Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
A study testing Pharmacist delivered smoking cessation program in people with Smoking Cessation, run by Qatar University at 2 sites in Qatar.
Trial summary
Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Pharmacist delivered smoking cessation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 2 sitesQatar
- Study dates
- Feb 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- use of other nicotine or tobacco products
- current use or use in the last 30 days of quit smoking aids or medications
- plan to leave Qatar in the next 12 months
- presence of any major medical condition that would prevent use of the nicotine replacement therapy including hypersensitivity to the products, history of or recent myocardial infarction, life-threatening arrhythmias, severe or worsening angina, uncontrolled hypertension and temporomandibular joint disease (in case of nicotine gum)
- pregnancy
- psychiatric illness or other debilitating condition that would interfere with participation in the study.
Trial locations and contacts
2 sites in 1 country.
Qatar2 sites
Primary Health Corporation (PHC) pharmacies
Doha
Qatar Petroleum pharmacies
Doha
About this study
Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths. Health care providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible health care providers and are uniquely situated to initiate behavior change among patients. Many western studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease smoking burden.
- Conditions
- Smoking Cessation
- Being tested
- Pharmacist delivered smoking cessation program, Control arm (i.e: regular care)
- Keywords
- Qatar, Pharmacy, Pharmacist, Smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist delivered smoking cessation programBehavioural
Also called Participants will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks.
The first session will be time-intensive taking around 30 minutes. In this session, the study pharmacist will facilitate the participant's preparation to quit. The participant will select a quit date within the next 2-4 weeks. The pharmacist will discuss with the participant the benefits of smoking cessation and will provide him or her with tailored behavioral and lifestyle strategies.
To prevent nicotine withdrawal symptoms, the participant will be offered nicotine replacement therapy (NRT) The first follow-up session will be scheduled after 1 week of the participant's quit day and will take around 20 minutes. In this session, the pharmacist will determine the participant's smoking status and assess the NRT tolerability.
- If the participant fails to quit smoking, the pharmacist will carefully review the participant's experience during the attempt to quit and will work through the identified problems
Control arm (i.e: regular care)Other
Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT). Receives: Other: Control arm (i.e: regular care) |
| Intervention arm | Experimental | Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy. The sessions will be set at a date and time that is convenient for both the pharmacist and the participant. The pharmacist will deliver the program at a time different from his or her pharmacy duty regular time. Receives: Behavioral: Pharmacist delivered smoking cessation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported 7-day Point Prevalence Abstinence
Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
Measured: 3 months
Self-reported 30 Day Smoking Abstinence
Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
Measured: 3 months
Self-reported Continuous Abstinence at 3 Months
Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
Measured: 3 months
Self-reported 7-day Point Prevalence Abstinence
Defined as having smoked no cigarettes for the previous 7 days
Measured: 6 months
Self-reported 30-day Point Prevalence Abstinence
Defined as having smoked no cigarettes in the last 30 days
Measured: 6 months
Self-reported Continuous Abstinence
Defined as having smoked no cigarettes since quit day
Measured: 6 months
Self-reported 7-day Point Prevalence Abstinence
Defined as having smoked no cigarettes for the previous 7 days
Measured: 12 months
Self-reported 30-day Point Prevalence Abstinence
Defined as having smoked no cigarettes in the last 30 days
Measured: 12 months
Self-reported Continuous Abstinence
Defined as having smoked no cigarettes since quit day at 12 months
Measured: 12 months
Objective Smoking Abstinence
Smoking abstinence as objectively verified by the CO exhaled test at 12 months
Measured: 12 months
Secondary outcomes (1)
Health Related Quality of Life
Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qatar University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamad Medical Corporation
- Responsible party
- Principal investigator, Dr. Maguy El Hajj, Qatar University
- Investigators
- Maguy S El Hajj, PharmD, Principal investigator, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123329
- Sponsor's protocol ID
- NPRP 4 - 716 - 3 - 203
- Status last verified
- Jun 2017
- First submitted
- 20 Apr 2014
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
El Hajj MS, Kheir N, Al Mulla AM, Shami R, Fanous N, Mahfoud ZR. Effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: a randomized controlled trial. BMC Public Health. 2017 Feb 20;17(1):215. doi: 10.1186/s12889-017-4103-4.
PubMed 28219367El Hajj MS, Kheir N, Al Mulla AM, Al-Badriyeh D, Al Kaddour A, Mahfoud ZR, Salehi M, Fanous N. Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial. Trials. 2015 Feb 26;16:65. doi: 10.1186/s13063-015-0570-z.
PubMed 25885807
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
- ClinicalTrials.gov ID
- NCT02123329
- Acronym / sponsor ID
- NPRP 4 - 716 - 3 - 203
- Conditions
- Smoking Cessation
- Keywords
- Qatar, Pharmacy, Pharmacist, Smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Qatar UniversityUniversity, hospital or other
- Collaborators
- Hamad Medical Corporation
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Posted 2 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths. Health care providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible health care providers and are uniquely situated to initiate behavior change among patients. Many western studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease smoking burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Other: Control arm (i.e: regular care)Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT). |
| Intervention arm | Experimental | Behavioral: Pharmacist delivered smoking cessation programParticipants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy. The sessions will be set at a date and time that is convenient for both the pharmacist and the participant. The pharmacist will deliver the program at a time different from his or her pharmacy duty regular time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- use of other nicotine or tobacco products
- current use or use in the last 30 days of quit smoking aids or medications
- plan to leave Qatar in the next 12 months
- presence of any major medical condition that would prevent use of the nicotine replacement therapy including hypersensitivity to the products, history of or recent myocardial infarction, life-threatening arrhythmias, severe or worsening angina, uncontrolled hypertension and temporomandibular joint disease (in case of nicotine gum)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist delivered smoking cessation programAlso: Participants will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks.The first session will be time-intensive taking around 30 minutes. In this session, the study pharmacist will facilitate the participant's preparation to quit. The participant will select a quit date within the next 2-4 weeks. The pharmacist will discuss with the participant the benefits of smoking cessation and will provide him or her with tailored behavioral and lifestyle strategies. To prevent nicotine withdrawal symptoms, the participant will be offered nicotine replacement therapy (NRT) The first follow-up session will be scheduled after 1 week of the participant's quit day and will take around 20 minutes. In this session, the pharmacist will determine the participant's smoking status and assess the NRT tolerability. • If the participant fails to quit smoking, the pharmacist will carefully review the participant's experience during the attempt to quit and will work through the identified problems | Behavioural | Intervention arm |
| Control arm (i.e: regular care)Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT). | Other | Control arm |
Primary outcome
Self-reported 7-day Point Prevalence Abstinence
Time frame: 3 months
Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
Self-reported 30 Day Smoking Abstinence
Time frame: 3 months
Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
Self-reported Continuous Abstinence at 3 Months
Time frame: 3 months
Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
Self-reported 7-day Point Prevalence Abstinence
Time frame: 6 months
Defined as having smoked no cigarettes for the previous 7 days
Self-reported 30-day Point Prevalence Abstinence
Time frame: 6 months
Defined as having smoked no cigarettes in the last 30 days
Self-reported Continuous Abstinence
Time frame: 6 months
Defined as having smoked no cigarettes since quit day
Self-reported 7-day Point Prevalence Abstinence
Time frame: 12 months
Defined as having smoked no cigarettes for the previous 7 days
Self-reported 30-day Point Prevalence Abstinence
Time frame: 12 months
Defined as having smoked no cigarettes in the last 30 days
Self-reported Continuous Abstinence
Time frame: 12 months
Defined as having smoked no cigarettes since quit day at 12 months
Objective Smoking Abstinence
Time frame: 12 months
Smoking abstinence as objectively verified by the CO exhaled test at 12 months
1 secondary outcome
Health Related Quality of Life
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28219367El Hajj MS, Kheir N, Al Mulla AM, Shami R, Fanous N, Mahfoud ZR. Effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: a randomized controlled trial. BMC Public Health. 2017 Feb 20;17(1):215. doi: 10.1186/s12889-017-4103-4.
- Derived from this study: PubMed 25885807El Hajj MS, Kheir N, Al Mulla AM, Al-Badriyeh D, Al Kaddour A, Mahfoud ZR, Salehi M, Fanous N. Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial. Trials. 2015 Feb 26;16:65. doi: 10.1186/s13063-015-0570-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maguy S El Hajj, PharmD principal investigator
Qatar University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist delivered smoking cessation program in people with Smoking Cessation, run by Qatar University at 2 sites in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported 7-day Point Prevalence Abstinence (time frame: 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.