Smoking cessation in pulmonary TB patients Not Applicable
Conditions
Interventions
Arm 1: Cytisine + Behavioural Support
Arm 2: Placebo + Behavioural Support
Cytisine:
Participants allocated to Arm 1 will receive their first five days
the session on day 0 will be aimed at encouraging tobacco users to see themselves as non-users,
Sponsors
University of York (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 04/09/2017: 1. Age at least 15 years (counted as adult TB patients in Pakistan) and 18 years in Bangladesh 2. Able to provide consent 3. Diagnosed with pulmonary tuberculosis (PTB) (smear positive or negative) in the last four weeks 4. Currently smokes tobacco 5. Willing to quit tobacco use Previous inclusion criteria: 1. Age at least 15 years (counted as adult TB patients in Pakistan and Bangladesh) and at least 18 years in Nepal 2. Able to provide consent 3. Diagnosed with pulmonary tuberculosis (PTB) (smear positive or negative) in the last four weeks 4. Currently smokes tobacco 5. Willing to quit tobacco use
Exclusion criteria
Exclusion criteria: Patients anticipated to have adverse effects either due to the study treatment or research burden, will be excluded. These will include those who are/have: 1. Retreatment TB, MDR TB, Miliary or Extra-pulmonary TB 2. Currently receiving Streptomycin (Category II anti-TB medication) and/or Para Amino Salicylic Acid (PASA) 3. Currently using any pharmacotherapy for tobacco dependence 4. Pregnant, lactating, or planning to become pregnant 5. Had myocardial infarction, stroke, or an attack of severe angina within the previous two weeks 6. Uncontrolled high blood pressure despite being on medication 7. Severe renal impairment (requiring dialysis) 8. Suffering from schizophrenia or known to be diagnosed with epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous abstinence at six months (self-report of tobacco use not more than five cigarettes/bidis/water pipe sessions/chew after the quit date), which is biochemically verified by Carbon Monoxide (CO) level of <10ppm and cotinine dip-stick level of < 3 in urine (Level 3 =100-200ng/mL cotinine), if using smokeless tobacco as well. | — |
Secondary
| Measure | Time frame |
|---|---|
| Abstinence, Lapses and Relapses Based on self-report alone or on the combination of self-report and CO/cotinine levels, these will include: 1. Point abstinence, defined as a self-report of not using tobacco in the previous 7 days at weeks 5 and 12, and verified by a CO level of <10ppm (or cotinine level < 3 for concomitant SLT users), at months 6 and 12. 2. Continuous abstinence at month 12 (only five instances of tobacco use allowed), biochemically verified as for the primary outcome at month 6. 3. Early-lapse, defined by a self-report of tobacco use (even once) after the quit date but having point abstinence at week 5. 4. Late-lapse, defined by a self-report of tobacco use (even once) between week 5 and week 12 but showing point abstinence at week 5 and week 12. 5. Early-relapse, defined by point abstinence at week 5 but a tobacco use status in later assessments. 6. Late-relapse, defined by point abstinence at week 5 and week 12 but a tobacco use status at month 6. TB outcomes 1. Clinical outcome: an eight-point clinical score (TB score) will be used to assess clinical outcome at baseline, week 5, 9, 12 and months 6 and 12. The score consists of signs and symptoms of TB (cough, chest pain, dyspnoea, anaemic conjunctivae, body mass index (BMI) <18 kg/m2, BMI <16 kg/m2, mid-upper arm circumference (MUAC) <220 mm, and MUAC <200 mm), each contributing one point. 2. Laboratory-based outcome: sputum conversion results at weeks 5, 9 and months 6 and 12, of those that were sputum positive at the time of diagnosis. 3. X-ray-based outcome: patients' chest X-rays taken at baseline, week 9 and months 6 and 12 will be graded according to the National Tuberculosis Association of the USA as normal, minimal, moderately advanced and far advanced TB 4. Programme outcomes: the proportion of tr | — |
Countries
Bangladesh, Pakistan
Contacts
Public ContactOmara Dogar
Outcome results
None listed