Hookah trial: the efficacy of varenicline in achieving abstinence among hookah smokers

• Register: ISRCTN
• Last refreshed on: 17 January 2022
• Main ID: ISRCTN94103375
• Date of registration: 01/12/2015
• Prospective Registration: Yes
• Primary sponsor: University of York
• Public title: Hookah trial: the efficacy of varenicline in achieving abstinence among hookah smokers
• Scientific title: The efficacy of varenicline in achieving abstinence among hookah smokers: a two-arm, double blind, randomised, placebo controlled trial
• Date of first enrolment: 01/01/2016
• Target sample size: 510
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN94103375
• Study type: Interventional
• Study design: Two-arm, double-blind, randomised, placebo controlled trial (Treatment)
• Phase: Phase III

Countries of recruitment

Pakistan

Contacts

• Name: Raana Zahid

• Name: Kamran Siddiqi

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

The efficacy of varenicline (either alone or in combination with other therapies) in hookah cessation is currently unknown.
Mental and Behavioural Disorders

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

WI194558

Source(s) of Monetary Support

Pfizer

Ethics review

Status:
Approval date:
Contact:

1. National Bioethics Committee (NBC) Pakistan 2. Health Sciences Research Governance Committee (HSRGC)

Results

• Results available: Yes
• Date Completed: 01/01/2017