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Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar

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ClinicalTrials.gov Identifier: NCT02123329
Recruitment Status : Completed
First Posted : April 25, 2014
Results First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Collaborator:
Hamad Medical Corporation
Information provided by (Responsible Party):
Dr. Maguy El Hajj, Qatar University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Pharmacist delivered smoking cessation program Other: Control arm (i.e: regular care) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
Study Start Date : February 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).
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).
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.
Behavioral: Pharmacist delivered smoking cessation program

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 Name: 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.



Primary Outcome Measures :
  1. 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

  2. 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. Self-reported Continuous Abstinence at 3 Months [ Time Frame: 3 months ]
    Self-reported continuous abstinence defined as having smoked no cigarettes since quit day

  4. Self-reported 7-day Point Prevalence Abstinence [ Time Frame: 6 months ]
    Defined as having smoked no cigarettes for the previous 7 days

  5. Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 6 months ]
    Defined as having smoked no cigarettes in the last 30 days

  6. Self-reported Continuous Abstinence [ Time Frame: 6 months ]
    Defined as having smoked no cigarettes since quit day

  7. Self-reported 7-day Point Prevalence Abstinence [ Time Frame: 12 months ]
    Defined as having smoked no cigarettes for the previous 7 days

  8. Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 12 months ]
    Defined as having smoked no cigarettes in the last 30 days

  9. Self-reported Continuous Abstinence [ Time Frame: 12 months ]
    Defined as having smoked no cigarettes since quit day at 12 months

  10. Objective Smoking Abstinence [ Time Frame: 12 months ]
    Smoking abstinence as objectively verified by the CO exhaled test at 12 months


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123329


Locations
Qatar
Primary Health Corporation (PHC) pharmacies
Doha, Qatar
Qatar Petroleum pharmacies
Doha, Qatar
Sponsors and Collaborators
Qatar University
Hamad Medical Corporation
Investigators
Principal Investigator: Maguy S El Hajj, PharmD Qatar University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Maguy El Hajj, Assistant Professor and Chair/ Clinical Pharmacy and Practice Section, Qatar University
ClinicalTrials.gov Identifier: NCT02123329     History of Changes
Other Study ID Numbers: NPRP 4 - 716 - 3 - 203
First Posted: April 25, 2014    Key Record Dates
Results First Posted: January 2, 2018
Last Update Posted: January 2, 2018
Last Verified: June 2017

Keywords provided by Dr. Maguy El Hajj, Qatar University:
Qatar
Pharmacy
Pharmacist
Smoking cessation

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action