Testing the feasibility of nicotine-assisted reduction to stop in pharmacies
| ISRCTN | ISRCTN54805841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54805841 |
| Secondary identifying numbers | G0802135 |
- Submission date
- 15/02/2010
- Registration date
- 18/03/2010
- Last edited
- 20/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Taina Taskila
Scientific
Scientific
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Multicentre randomised 2x2 factorial design controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Testing the feasibility of nicotine-assisted reduction to stop in pharmacies: a 2x2 factorial trial |
| Study acronym | RedPharm |
| Study objectives | 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(s) | Ethics approval pending from South Birmingham REC on 16/03/2010 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 02/06/2010 |
| Completion date | 01/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 320 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/06/2010 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
c/o Dr Brendan Laverty
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) - National Prevention Research Initiative (NPRI) (ref: G0802135)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/03/2012 | Yes | No | |
| Results article | results | 17/02/2017 | Yes | No |
Editorial Notes
20/02/2017: Publication reference added.
