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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002498-11 | EudraCT Number |
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Pilot study of a new nicotine replacement therapy for smoking cessation.
This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Standard NRT user direction |
|
| 2 | Experimental | Novel NRT user direction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine replacement therapy | Drug | Nicotine replacement therapy with Standard NRT user direction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean hourly and daily number of doses used | throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of NRT use occasions per day | Week 1, 2, and 3 | |
| Ratings of craving/urge to smoke and withdrawal symptoms | Day 1-14, and Day 20 | |
| Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Kruse, PhD | Global Medical Affairs & Clinical Research, McNeil AB, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Primary Care and General Practice, University of Birmingham | Birmingham | B15 2TT | United Kingdom | |||
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Nicotine replacement therapy | Drug | Nicotine replacement therapy with a Novel NRT user direction |
|
|
| Day 1-21 |
| Cotinine levels | At baseline and week 3 |
| Product acceptability | At week 3 visit |
| Safety Assessments will consist of monitoring and recording all non-serious Adverse Events and Serious Adverse Events , their frequency, severity, seriousness, and relationship to the investigational product. | throughout duration of the study (+ 30 days for spontaneous SAEs) |
| Tobacco Dependence Research Centre at Barts and The London Queen Mary's School of Medicine and Dentistry |
| London |
| E1 2AD |
| United Kingdom |