Public Health Mental and Behavioural Disorders
Conditions
Interventions
This trial has a 2x2 factorial design. The pharmacists will recruit 16 patients per pharmacy
160 smokers altogether. Participants will be randomised in sealed envelopes to receive:
1. Behavioural support
1.1. 52 weeks
1.2. 4 weeks
The pharmacist will give support for 52 weeks by inviting part
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 years or older 2. Smokes at least 10 cigarettes or 12.5g of loose tobacco daily as roll your own cigarettes, or blows 15ppm or above on CO recording 3. Do not intend to stop in the next month, but are prepared to reduce their consumption with any of the programmes offered 4. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate and be randomised to either arm and have either a telephone or email for follow-up
Exclusion criteria
Exclusion criteria: 1. Currently using other NRT, bupropion, nortriptyline, mecamylamine, reserpine, or varenicline, or undergoing any treatment for tobacco dependence (e.g. acupuncture), 2. Unstable angina pectoris, myocardial infarction, or cerebrovascular accident during the last 3 weeks, 3. Severe cardiac arrhythmia 4. Currently uncontrolled hyperthyroidism 5. Active phaeocromocytoma 6. Pregnancy, lactation or intended pregnancy 7. Participation in other medicinal trials within the last three months and during study participation, 8. Previously had severe skin reactions to nicotine patches or severe eczema or other skin diseases that make patch use hazardous or undesirable 9. Severe acute or chronic medical or psychiatric condition or previously diagnosed clinically important renal or hepatic disease, that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Hospital Anxiety Depression Scale (HADS) measured at baseline and the end of follow up (52 weeks) 2. Smoking behaviour measured at baseline 3. Service satisfaction questionnaire at end of follow up (52 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cessation activity: at 4 wks, 8 wks, 12, 16, 20, 24 etc. every month until the end of the trial (52 weeks) (11 measures) | — |
Countries
United Kingdom
Outcome results
None listed