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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA243552 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study will evaluate if Automated Treatment performs better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Active Comparator | Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's tobacco quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress. |
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| Automated Treatment | Experimental | Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | Participants will be provided with a 10-week supply of nicotine patches |
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| Measure | Description | Time Frame |
|---|---|---|
| Self Reported 7 Day Abstinence Smoking Status | Participants will self report 7-day abstinence smoking status | 12 Month Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Status by Saliva Cotinine Kit | Investigators will verify smoking status by collecting cotinine sample from a saliva cotinine kit. | 12 Month Follow-Up |
| Self Reported 24 Hours Smoking Abstinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damon J Vidrine, Dr.PH | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34787590 | Derived | Vidrine DJ, Bui TC, Businelle MS, Shih YT, Sutton SK, Shahani L, Hoover DS, Bowles K, Vidrine JI. Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 17;10(11):e33183. doi: 10.2196/33183. |
| Label | URL |
|---|---|
| Moffitt Clinical Trial Search | View source |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
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| Counseling | Behavioral | Phone counseling with the state tobacco quitline. |
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| Nicotine lozenge | Drug | Participants will be provided with a 10-week supply of nicotine lozenges |
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| Smartphone-delivered automated treatment | Behavioral | An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant |
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Number of participants who report they quit smoking for 24 hours
| 12 Month Follow-Up |
| 30 Day Smoking Abstinence | Number of participants who report they quit smoking for 30 days | 12 Month Follow-Up |
| Continuous Smoking Abstinence | Number of participants who report they quit smoking | 12 Month Follow-Up |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |