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Completed

NCT Number: NCT02123329

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Health Corporation (PHC) pharmacies, Doha, Qatar

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacist delivered smoking cessation program

Behavioral

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: 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.

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Qatar University

Other

Collaborators

  • Hamad Medical Corporation

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 25, 2014
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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