The efficacy of varenicline (either alone or in combination with other therapies) in hookah cessation is currently unknown. Mental and Behavioural Disorders
Conditions
Interventions
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 tria
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Pakistan
Contacts
Public ContactRaana Zahid
Outcome results
None listed