Smoking Cessation, Tobacco Dependence
Conditions
Keywords
Smoking cessation, Tobacco dependence, Varenicline, Nicotine Replacement Therapy, Combination therapy
Brief summary
Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.
Interventions
DRUGNicotine Patch
Varenicline + nicotine patch
DRUGPlacebo
Varenicline + placebo patch
DRUGVarenicline
All participants will receive a standard dose of varenicline (12 weeks).
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Smokers seeking treatment * Aged 18 and over * Consenting to take part in the trial
Exclusion criteria
* Pregnant or breastfeeding * End-stage renal disease * Unable to fill in questionnaires in English * Previous allergy to Varenicline * Previous allergy to Nicotine Patches Previous allergy to varenicline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale | 1 week | Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validated abstinence rates over weeks 1-12 post target quit date | 12 weeks post target quit date | — |
| Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale | 4-weeks post quitting | — |
| Profile of all adverse effects reported up to 12-weeks post quitting | Up to 12-weeks post quitting | — |
| Ratings of urges to smoke 24 hours after the target quit date | 24 hours | Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale |
Countries
United Kingdom
Outcome results
None listed