Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0802135
Study information
Scientific title
Testing the feasibility of nicotine-assisted reduction to stop in pharmacies: a 2x2 factorial trial
Acronym
RedPharm
Study hypothesis
This pilot study aims to examine the feasibility of nicotine-assisted reduction to stop (NARS) in pharmacies and also to see if behavioural support and the length of the trial affects the success rate for cessation. The trial will test how well pharmacists can be trained to implement NARS and how this is received by smokers and by pharmacists.
Primary aims:
To test the processes, examine implementation issues, and reactions to the programme of those involved
Secondary aims:
1. Investigate whether behavioural support is more effective than no support
2. Investigate whether shorter reduction programmes are more effective
Ethics approval
Ethics approval pending from South Birmingham REC on 16/03/2010
Study design
Multicentre randomised 2x2 factorial design controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Public Health
Intervention
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 participants to set a treatment goal and provide advice on how to reduce cigarettes. Participants in the 4-week supported programme will be given the same advice with the reduction but with a different schedule. Participants will be provided with a weeks worth of Nicotine Replacement Therapy every week for the duration of their participation in the trial.
2. No support
2.1. 52 weeks
2.2. 4 weeks
Participants in the no support arms will not be given advice or support. Instead they will be given a leaflet that describes the reduction programmes, and encourages use of Nicotine Replacement Therapy (NRT) to support the reduction.
The trial will run for 52 weeks regardless of the trial arm, it is only the way they reduce the amount they smoke that will differ. The NRT will be given by the recruiting pharmacist. The participants will also be asked to provide a CO2 reading at their first appointment, at the last appointment and also after every time they have gone smoke free for a month.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
Cessation activity: at 4 wks, 8 wks, 12, 16, 20, 24 etc. every month until the end of the trial (52 weeks) (11 measures)
Overall trial start date
02/06/2010
Overall trial end date
01/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
320
Participant 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
Recruitment start date
02/06/2010
Recruitment end date
01/07/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Birmingham
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) - National Prevention Research Initiative (NPRI) (ref: G0802135)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22410103
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28212652