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| ID | Type | Description | Link |
|---|---|---|---|
| H09-183-2 | Other Identifier | Hartford Hospital |
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| Name | Class |
|---|---|
| UConn Health | OTHER |
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We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.
Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotrol with Behavioral Counseling | Experimental | Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotrol Inhaler | Drug | 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Inhaler Use | Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cartridge Use | Baseline to 4 weeks | |
| Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks. | Baseline to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Oncken, MD MPH | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotrol Inhaler With Behavioral Counseling | Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotrol Inhaler With Behavioral Counseling | Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Days of Inhaler Use | Posted | Mean | Standard Deviation | days | Baseline to 4 weeks |
|
|
Baseline to delivery, up to 27 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 | Nicotrol Inhaler With Behavioral Counseling | Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | "Serious" | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Other | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Oncken | UConn Health | 860-679-3425 | oncken@uchc.edu |
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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 |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Cartridge Use | Posted | Mean | Standard Deviation | cartridges per day | Baseline to 4 weeks |
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|
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| Secondary | Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks. | Posted | Mean | Standard Deviation | reduction in number of CPD | Baseline to 4 weeks |
|
|
|
| 1 |
| 8 |
| 4 |
| 8 |
| Headache | Nervous system disorders | Other | Systematic Assessment |
|
| Lightheadedness | General disorders | Other | Systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Other | Systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |