Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022334-92 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline + Active Patch | Experimental | Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch |
|
| Varenicline + Placebo Patch | Placebo Comparator | Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | Varenicline + nicotine patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale | Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Al-Rehan A A Dhanji, MB BS BSc MRCS | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tobacco Dependence Research and Treatment Unit | London | E1 2JH | United Kingdom | |||
| Tobacco Dependence Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. | |
| 23718718 | Derived | Hajek P, Smith KM, Dhanji AR, McRobbie H. Is a combination of varenicline and nicotine patch more effective in helping smokers quit than varenicline alone? A randomised controlled trial. BMC Med. 2013 May 29;11:140. doi: 10.1186/1741-7015-11-140. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Varenicline + placebo patch |
|
|
| Varenicline | Drug | All participants will receive a standard dose of varenicline (12 weeks). |
|
|
| 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 | Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale | 24 hours |
| London |
| E1 2JH |
| United Kingdom |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
Not provided
Not provided