- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02123329
Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Doha, Qatar
- Primary Health Corporation (PHC) pharmacies
-
Doha, Qatar
- Qatar Petroleum pharmacies
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Eligible participants are:
- patients aged 18 years and older who currently smoke one or more cigarettes daily for 7 days, are motivated to quit i.e.: in the preparation stage of the stage-of-change model, able to communicate in Arabic or English and are willing and capable of attending the scheduled sessions at the study pharmacies.
Exclusion criteria are:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control arm
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).
|
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).
|
Experimental: Intervention arm
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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
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
|
3 months
|
Self-reported Continuous Abstinence at 3 Months
Time Frame: 3 months
|
Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
|
3 months
|
Self-reported 7-day Point Prevalence Abstinence
Time Frame: 6 months
|
Defined as having smoked no cigarettes for the previous 7 days
|
6 months
|
Self-reported 30-day Point Prevalence Abstinence
Time Frame: 6 months
|
Defined as having smoked no cigarettes in the last 30 days
|
6 months
|
Self-reported Continuous Abstinence
Time Frame: 6 months
|
Defined as having smoked no cigarettes since quit day
|
6 months
|
Self-reported 7-day Point Prevalence Abstinence
Time Frame: 12 months
|
Defined as having smoked no cigarettes for the previous 7 days
|
12 months
|
Self-reported 30-day Point Prevalence Abstinence
Time Frame: 12 months
|
Defined as having smoked no cigarettes in the last 30 days
|
12 months
|
Self-reported Continuous Abstinence
Time Frame: 12 months
|
Defined as having smoked no cigarettes since quit day at 12 months
|
12 months
|
Objective Smoking Abstinence
Time Frame: 12 months
|
Smoking abstinence as objectively verified by the CO exhaled test at 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Related Quality of Life
Time Frame: 6 month
|
Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
|
6 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maguy S El Hajj, PharmD, Qatar University
Publications and helpful links
General 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.
- El 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NPRP 4 - 716 - 3 - 203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on Control arm (i.e: regular care)
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Imperial College LondonCompleted
-
Mahidol UniversityUnknown
-
Rabin Medical CenterTerminated
-
Portsmouth Hospitals NHS TrustBritish Lung Foundation; University of OxfordCompletedMesothelioma, MalignantUnited Kingdom, Australia
-
Université Catholique de LouvainUniversity Hospital of Mont-GodinneRecruitingCerebral PalsyBelgium
-
University of AlbertaUniversity Hospital FoundationCompletedAtrial FibrillationCanada
-
Université Catholique de LouvainUniversity Hospital of Mont-GodinneRecruiting
-
Abu Dhabi Stem Cells CenterActive, not recruitingType 1 DiabetesUnited Arab Emirates
-
The University of Hong KongCompletedMild Dementia | Moderate DementiaHong Kong
-
Church & Dwight Company, Inc.CompletedGingivitis | PlaqueCanada