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| Name | Class |
|---|---|
| Southern Connecticut State University | UNKNOWN |
| University of New Haven | UNKNOWN |
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This study is a randomized-controlled clinical trial which evaluates the efficacy of physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in promoting cigarette smoking in smokers enrolled in college.
The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text messaging | Experimental | Smoking counseling, nicotine patch, text messaging |
|
| Standard of care | Active Comparator | Smoking counseling, nicotine patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking counseling | Behavioral |
| ||
| Text messaging |
| Measure | Description | Time Frame |
|---|---|---|
| Study Enrollment- Number of Participants Who Join the Study | We will report the number of persons who join the study. | baseline |
| Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. | We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit. | 6- and 12- weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence | biochemically confirmed point prevalence of self reported past 7-day abstinence | 6- and 12- weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepa R Camenga, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Connecticut State University | New Haven | Connecticut | 06515 | United States |
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Recruitment open from January 2015 to May 2016. Recruited from local college campuses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Text Messaging | Smoking counseling, nicotine patch, text messaging Smoking counseling Nicotine patch Text messaging |
| FG001 | Standard of Care | Smoking counseling, nicotine patch Smoking counseling Nicotine patch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Text Messaging | Smoking counseling, nicotine patch, text messaging Smoking counseling Text messaging Nicotine patch |
| BG001 | Standard of Care | Smoking counseling, nicotine patch Smoking counseling Nicotine patch |
| 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 | Study Enrollment- Number of Participants Who Join the Study | We will report the number of persons who join the study. | Posted | Count of Participants | Participants | baseline |
|
|
From January 2015 through August 2016
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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 | Text Messaging | Smoking counseling, nicotine patch, text messaging Smoking counseling Nicotine patch Text messaging |
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This is a pilot and feasibility study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deepa Camenga, MD | Yale University | 203-737-8310 | deepa.camenga@yale.edu |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Behavioral |
|
| Nicotine patch | Drug |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. | We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit. | Posted | Count of Participants | Participants | 6- and 12- weeks |
|
|
|
| Secondary | Smoking Abstinence | biochemically confirmed point prevalence of self reported past 7-day abstinence | Posted | Count of Participants | Participants | 6- and 12- weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Standard of Care | Smoking counseling, nicotine patch Smoking counseling Nicotine patch | 0 | 20 | 0 | 20 |
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