Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SM 07-01 |
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
The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus) can help adult smokers to reduce and eventually completely quit smoking.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Swedish snus ad libitum as a substitute for cigarettes |
|
| 2 | Placebo Comparator | Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swedish snus (smokeless tobacco) | Other | Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking reduction defined as a reduction in self-reported number of smoked cigarettes per day >50% compared to base-line, verified by a reduction in CO in exhaled air of >1 ppm compared to base-line | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm | 3, 6, 9 and 12 months | |
| Clinical tests and biomarkers relevant for exposure to tobacco | 3, 6, 9, and 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gordana Joksic, Ph D | Institute for Nuclear Research "Vinca", Belgrade, Serbia | Principal Investigator |
| Robert Nilsson, Ph D, Prof | Stockholm University, Stockholm, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nuclear Sciences "Vinca" | Belgrade | 11001 | Serbia | |||
| Ambulanta Medicine Rada, Nis-Jugopetrol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21914165 | Result | Joksic G, Spasojevic-Tisma V, Antic R, Nilsson R, Rutqvist LE. Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation. Harm Reduct J. 2011 Sep 13;8:25. doi: 10.1186/1477-7517-8-25. |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D000074264 | Smoking Reduction |
| D016540 | Smoking Cessation |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D014030 | Tobacco, Smokeless |
| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Onico |
| Other |
Tobacco-free, nicotine-free placebo snus, 2 sachet sizes (1.0 g, 0.5 g), 2 flavors (same as in the experimental arm). Usage ad libitum. |
|
|
| Smoking reduction | Smoking reduction according to self-report | 12, 24, 36 and 48 months |
| Smoking reduction | Smoking reduction compared to baseline according to self-report | 12, 24, 36 and 48 months |
| New Belgrade |
| 110 70 |
| Serbia |