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Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes.
Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single open-label treatment arm | Experimental | Adult smokers willing to quit were treated with escalating doses of transdermal nicotine patch (Nicoderm) and brief counselling if they continued to smoke over a 9-week treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicoderm | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Carbon Monoxide Levels | Expired Co levels were measured to confirm smoking status | measured at week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | self reported # cigarettes per day | Week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter L. Selby, MBBS | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23963055 | Result | Selby P, Andriash K, Zawertailo L, Persad D, Zack M, Busto UE. Escalating doses of transdermal nicotine in heavy smokers: effects on smoking behavior and craving. J Clin Psychopharmacol. 2013 Oct;33(5):667-74. doi: 10.1097/JCP.0b013e31829a829d. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Therapy + Counselling | Nicotine replacement therapy + brief counselling |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Participants | All eligible enrolled participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Carbon Monoxide Levels | Expired Co levels were measured to confirm smoking status | Posted | Mean | Standard Deviation | parts per million | measured at week 10 |
|
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Participants | participants who enrolled in the study | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| adverse event- respiratory infection and colds | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse event (non-serious) unrelated to NRT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Selby | Centre for Addiction and Mental Health | 416-535-8501 | 36859 | peter.selby@camh.ca |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mean Cigarettes per day | Mean | Standard Deviation | cigarettes per day |
|
| Carbon monoxide gas (CO) reading | Mean | Standard Deviation | ppm |
|
| No. of previous serious quit attempts | Mean | Standard Deviation | Quit attempts |
|
| No. years smoking | Mean | Standard Deviation | years |
|
| Fagerstrom Test of Nicotine Dependence | A standard test to assess nicotine dependence completed by the subject. The yes/ no responses are scored 0-1 and multiple choice answers are scored 0-3. Items are summed to yield a total score of 0-10. Total score indicates level of nicotine dependence. 0-2 (Low); 3-5 (Low-moderate); 5-7 (Moderate); 8-10 (High). | Mean | Standard Deviation | units on a scale |
|
| Hamilton Depression Rating Scale (HAM-D) | This measure is used to assess level of depression. There are 21 items and the score is based on the first 17 items. 8 items are scored 0-4. 9 items are scored 0-2. Total score determines level of depression. 0-7 (normal); 8-13 (mild depression); 14-18 (moderate depression); 19-22 (severe depression); => 23 (very severe depression) | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory (BDI) score | This self report scale measures level of depression. the response of each of the 21 items ranges from 0-3. The total score (range 0-63) reflects level of depression. 0-10 (normal) 11-16 (moderate) 17-20 (borderline) 21-30 (moderate) 21-40 (Severe) > 40 (extreme) | Mean | Standard Deviation | units on a scale |
|
|
| Secondary | Smoking Cessation | self reported # cigarettes per day | Posted | Mean | Standard Deviation | cigarettes per day | Week 10 |
|
|
|
| 23 |
| 0 |
| 23 |
| 17 |
| 23 |
|
| Skin irritation | Product Issues | Systematic Assessment | Reaction to Nicotine patch -Skin irritation |
|
| sleep disturbance | Product Issues | Systematic Assessment | reaction to nicotine patch |
|
| Nausea and Vomitting | Product Issues | Systematic Assessment | Reaction to nicotine patch |
|
| Emotional Distress | Social circumstances | Systematic Assessment |
|
| Depressive Symptoms | Psychiatric disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |