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| Name | Class |
|---|---|
| Truth Initiative | OTHER |
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The overall objective of this project is to develop and pilot-test a web-based smoking cessation program that specifically addresses heavy drinking (HD). The project builds upon a well-established, free evidence-based smoking cessation website, BecomeAnEX.org ("EX"), which is supported by Truth Initiative, a national non-profit public health organization, and its research arm, the Schroeder Institute. Investigators will develop an alternative version of BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse, health effects of alcohol (including moderate drinking recommendations) along with related worksheets, feedback materials, and links to resources for drinking. Once a version of BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered BecomeAnEX users. The study will gather participant feedback on the site as well as site use metrics (e.g., number of logins, number of pages viewed, use of interactive components) and will revise EX-HD in response to this feedback in preparation for Stage 1b work. Stage 1b will use the updated EX-HD version to run a small scale randomized clinical trial where 120 participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Web-based Smoking Cessation | Active Comparator | A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. |
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| Alcohol-focused Web-Based Smoking Cessation | Experimental | A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Web-based Smoking Cessation | Behavioral | A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month | Self-report abstinence from smoking | 1 month after enrollment |
| Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months | Self-report abstinence from smoking | 6 months after enrollment |
| Number of Heavy Drinking Days at 1 Month | Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men | 1 month after enrollment |
| Number of Heavy Drinking Days at 6 Months | Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men | 6 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
1. history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Alcohol and Addiction Studies, Brown University | Providence | Rhode Island | 02912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32348286 | Derived | Kahler CW, Cohn AM, Costantino C, Toll BA, Spillane NS, Graham AL. A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e7570. doi: 10.2196/formative.7570. |
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Study recruitment was conducted online over 7 weeks (May to July, 2017). Only newly registered users of BecomeAnEX.org were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Web-based Smoking Cessation | A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2019 | Aug 23, 2019 |
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| Alcohol-focused Web-Based Smoking Cessation | Behavioral | A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. |
|
| FG001 | Alcohol-focused Web-Based Smoking Cessation | A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish. Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Web-based Smoking Cessation | A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. |
| BG001 | Alcohol-focused Web-Based Smoking Cessation | A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish. Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month | Self-report abstinence from smoking | Posted | Count of Participants | Participants | 1 month after enrollment |
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| Primary | Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months | Self-report abstinence from smoking | Posted | Count of Participants | Participants | 6 months after enrollment |
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| Primary | Number of Heavy Drinking Days at 1 Month | Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men | Posted | Mean | Standard Deviation | Days | 1 month after enrollment |
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| Primary | Number of Heavy Drinking Days at 6 Months | Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men | Posted | Mean | Standard Deviation | Days | 6 months after enrollment |
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6 Months
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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 | Standard Web-based Smoking Cessation | A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. | 0 | 61 | 0 | 61 | 0 | 61 |
| EG001 | Alcohol-focused Web-Based Smoking Cessation | A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish. Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. | 0 | 58 | 0 | 58 | 0 | 58 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kahler | Brown University | 401 863-6651 | christopher_kahler@brown.edu |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 8, 2016 | Aug 23, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D004327 | Drinking Behavior |
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| ID | Term |
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| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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| Participants |
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