Plain English Summary
Background and study aims
Hookahs are water pipes used to smoke tobacco. It has many of the same health risks as cigarette smoking. The number of young people taking up the habit has increased across the globe, including in the United States, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioural and pharmacological (drug) therapies is available to support people in quitting cigarette smoking, however, little evidence exists on whether they work to help people who want to stop hookah smoking. The aim of this study is to test how well the drug varenicline performs at helping people quit hookah smoking when combined with behavioural support by using a biochemically validated technique (measuring carbon monoxide levels) to check for the absence of smoking.
Who can participate?
Adults who have been hookah smokers on a daily basis for at least six-months and are willing to quit smoking.
What does the study involve?
Participants are randomly allocated to one of two different groups. Those in group 1 are given varenicline and behavioural support. Those in group 2 are given a placebo and behavioural support. All participants then have their carbon monoxide levels measured after 5 weeks, 12 weeks and 25 weeks of the study starting. Participants are also asked to report on whether they have stopped smoking, whether they lapsed early or late on into the study (even if they smoked just the once).
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Three district hospitals in Punjab, Pakistan
When is the study starting and how long is it expected to run for?
July 2015 to January 2017
Who is funding the study?
Pfizer (USA)
Who is the main contact?
Dr Raana Zahid
guleraanazahid2@gmail.com
Trial website
Contact information
Type
Public
Primary contact
Dr Raana Zahid
ORCID ID
Contact details
Orange Grove Farm
Main Korung Road
Banigala
Islamabad
44000
Pakistan
92-344-5055404
guleraanazahid2@gmail.com
Type
Scientific
Additional contact
Dr Kamran Siddiqi
ORCID ID
Contact details
Department of Health Sciences/Hull York Medical School
Room 105a
First floor
ARRC Building
University of York
Hesligton
York
YO10 5DD
United Kingdom
+44 07970 544872
kamran.siddiqi@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WI194558
Study information
Scientific title
The efficacy of varenicline in achieving abstinence among hookah smokers: a two-arm, double blind, randomised, placebo controlled trial
Acronym
Hookah Trial
Study hypothesis
Is varenicline co-administered with behavioural support more efficacious in achieving six-month’s continuous abstinence from all forms of tobacco smoking among hookah smokers than a combination of placebo and behavioural support?
The aim is to assess the efficacy of varenicline when added to behavioural support for smoking cessation, by measuring biochemically validated continuous abstinence from week 5 to 25 in hookah smokers.
Ethics approval
1. National Bioethics Committee (NBC) Pakistan
2. Health Sciences Research Governance Committee (HSRGC)
Study design
Two-arm, double-blind, randomised, placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
The efficacy of varenicline (either alone or in combination with other therapies) in hookah cessation is currently unknown.
Intervention
Once enrolled, participants in the trial will be randomised to receive behavioural support either with varenicline or with placebo tablets. A quit date will be set one week after enrolling in the trial. The components of the treatment arms are described below.
As part of a previous smoking cessation trial conducted in Pakistan (ASSIST trial),26 we have already developed an effective behavioural support intervention to help people to quit smoking. However, this will need adaptation to incorporate hookah smoking, in particular addressing those specific behavioural determinants, which are associated with hookah smoking. Therefore, with the help of an expert panel (comprising of a behavioural scientist, tobacco cessation specialist, public health academic, and an epidemiologist), we will undertake an iterative process to identify the required modifications and model these into the existing intervention, in order to make it suitable for hookah smokers. We will also modify the associated materials and then pre-test them with the expert panel.
Intervention type
Drug
Phase
Phase III
Drug names
Varenicline
Primary outcome measure
Self-reported continuous abstinence for at least six months (no smoking allowed in the seven days prior to each of the three assessments) which is biochemically verified by a CO level of <10ppm measured by MicroCO (Micro Medical ltd., United Kingdom) at week 5, week 12, and week 25. When a participant self-reports abstinence with an elevated CO level of >10ppm on any of the three assessments, we will use salivary kits for checking cotinine in such cases. Depending on the findings of cotinine, the participant will categorised as smoker or not.
Secondary outcome measures
1. Point abstinence, defined as a self-report of not smoking in the previous 7 days and verified by a CO level of <10ppm, at week 5, week 12, and week 25
2. Early-lapse, defined by a self-report of smoking (even once) after the quit date but having point abstinence at week 5
3. Late-lapse, defined by a self-report of smoking (even once) between week 5 and week 12 but showing point abstinence at week 5 and week 12
4. Early-relapse, defined by a point abstinence at week 5 but a smoking status in later assessments
5. Late-relapse, defined by a point abstinence at week 5 and week 12 but a smoking status at week 25
6. Differences in the point and continuous abstinences, lapses and relapses between exclusive hookah-smokers and those that combine it with other forms of smoking tobacco
All outcomes will be measured before and after the intervention in each of the study’s arms.
Overall trial start date
01/07/2015
Overall trial end date
01/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults (both males and females) at least 18 years of age
2. Smoked hookah on a daily basis for at least six months (validated by breath carbon monoxide [CO] > 10ppm). Daily smoking is defined if person smokes > 25 days in a month
3. Motivated to give up all forms of smoking completely
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
510
Participant exclusion criteria
People will be excluded if they:
1. Have used any pharmacotherapy for tobacco dependence (including nicotine replacement therapy and electronic cigarettes) in the last 30 days
2. Are pregnant, lactating, or planning to become pregnant
3. Have a medical condition requiring hospitalisation
4. Have used varenicline in the past and had an allergic reaction
5. Have a history of heart disease including unstable angina, untreated cardiac arrhythmia, myocardial infarction, or have a cardiac procedure (last three months)
6. Have uncontrolled hypertension or a history of stroke
7. Have a history of chronic kidney disease
8. Have a history of epilepsy
9. Have suicidal ideation or a history of self-harm
10. Have a history of schizophrenia, psychosis, or bipolar disorder
11. Current moderate or severe depression
12. Current use of smokeless tobacco
13. Active use of substances (including alcohol misuse) other than tobacco
Recruitment start date
01/01/2016
Recruitment end date
30/06/2016
Locations
Countries of recruitment
Pakistan
Trial participating centre
District Headquarters Hospital, Chakwal
Chakwal
48800
Pakistan
Trial participating centre
District Headquarters Hospital, Khushab
Khushab
41000
Pakistan
Trial participating centre
District Headquarters Hospital, Mandi Bahauddin
Mandi Bahauddin
50400
Pakistan
Sponsor information
Organisation
University of York
Sponsor details
Department of Health Sciences
The University of York
SeebohmRowntree Building
Heslington
York
YO10 5DD
York
YO10 5DD
United Kingdom
+44 07970 544872
kamran.siddiqi@york.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Pfizer
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Intention to publish date
01/01/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28077163