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| Name | Class |
|---|---|
| Danish Research Foundation, FSS, Copenhagen, Denmark | UNKNOWN |
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To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches.
Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.
This is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). After ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. Every ½ year cholesterol, blood pressure, lung function and BMI will be assessed and used to enhance adherence of the participants in this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smokeless Tobacco | Experimental | Smokeless Tobacco and individual visits |
|
| Nicotine tablets | Active Comparator | Nicotine tablets |
|
| 3 | Placebo Comparator | 7-mg nicotine patch acts as placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smokeless tobacco (Oliver Twist pellets) | Drug | individual visits with counseling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence from smoking after ½ year (point and continuous abstinence) | 6 months from entry |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events between 3 arms | Up to 6 months from entry | |
| Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL) | 3 and 6 months from entry | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Tønnesen, M.D., Ph.D. | Chair dept. pulm. medicine, Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. pulmonary medicine Y, Gentofte University Hospital | Copenhagen | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D014030 | Tobacco, Smokeless |
| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| smoking cessation counseling |
| Behavioral |
individual visits |
|
| Adherence to study |
| 6,12,24 months from entry |
| Effect of retreatment (abstinence after 1, 1½ and 2 years) | 12,18 and 24 months from entry |
| Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status | 6,12,24 months from entry |
| D001519 | Behavior |