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The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers.
The three-arm randomized controlled trial compares Arm 1) standard smoking cessation plus support text messages, 2) enhanced cue exposure treatment (lab-based + interactive SMS texting) + D-cycloserine placebo, Arm 3)will include a combination of cognitive behavioral cessation counseling, enhanced cue exposure treatment (lab-based + interactive SMS texting) and a cognitive-enhancing drug - D-cycloserine. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an inperson follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Cognitive behavioral cessation counseling | Active Comparator | Standard smoking cessation plus support text messages |
|
| Placebo Comparator: Counseling and placebo drug intervention | Placebo Comparator | enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo |
|
| Active Comparator: Counseling and active drug intervention | Experimental | enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral cessation counseling | Behavioral | Standard smoking cessation plus support text messages |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Completion of at Least 2 Study Visits | Feasibility will be determined by number of participants that complete at least 2 study visits. | Approximately 8 weeks |
| Number of Participants Who Rated the Intervention Acceptable | Acceptability will be determined by the number of patients rating the intervention usefulness in the experimental and control arms on a 7-point Likert scale, where 1=extremely useless and 7=extremely useful. | Approximately 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Validated Cessation | Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention. | 1 week post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Pollak, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center - Cancer Prevention, Detection and Control | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33109394 | Derived | Pollak KI, Oliver JA, Pieper C, Davis JM, Gao X, Noonan D, Kennedy D, Granados I, Fish LJ. Cue-based treatment for light smokers: A proof of concept pilot. Addict Behav. 2021 Mar;114:106717. doi: 10.1016/j.addbeh.2020.106717. Epub 2020 Oct 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Cognitive Behavioral Cessation Counseling | Standard smoking cessation plus support text messages Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages |
| FG001 | Placebo Comparator: Counseling and Placebo Drug Intervention | enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages Counseling and placebo drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo |
| FG002 | Active Comparator: Counseling and Active Drug Intervention | enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
In the comparator standard counseling, one enrolled patient withdrew prior to completing the baseline survey. Three participants in the active comparator arm did not complete the baseline survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Cue-based Treatment | Enhanced cue exposure treatment (lab-based + interactive SMS texting) Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages |
| BG001 | Comparator: Standard Counseling |
| 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 | Number of Participants With Completion of at Least 2 Study Visits | Feasibility will be determined by number of participants that complete at least 2 study visits. | Only one participant in the "Active Comparator" arm completed the study. | Posted | Count of Participants | Participants | Approximately 8 weeks |
|
2 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 | Experimental: Cognitive Behavioral Cessation Counseling | Standard smoking cessation plus support text messages Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages |
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Findings are not conclusive due to the pilot nature of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathryn I Pollak | Duke Cancer Institute | 919-681-4757 | kathryn.pollak@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2020 | Feb 4, 2021 | ICF_002.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2020 | Feb 4, 2021 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Counseling and placebo drug intervention | Behavioral | Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo |
|
| Counseling and active drug intervention | Drug | Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. |
|
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages |
| BG002 | Active Comparator: Counseling and Active Drug Intervention | enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education: Some college or college grad | Count of Participants | Participants |
|
| Employment status: Employed | Count of Participants | Participants |
|
| Type of smoker | Count of Participants | Participants |
|
| Cigarettes per day | Mean | Standard Deviation | cigarettes per day |
|
| Nicotine Dependence | Measured by the Fagerstrom Test For Nicotine Dependence (FTND). The FTND has a range of 0-10. The higher the Fagerstrom score, the more intense is the patient's physical dependence on nicotine. | Mean | Standard Deviation | units on a scale |
|
| Native Light Smoker | Native light smoker is defined as a participant smoker who has never smoked more than 10 cigarettes per day | Count of Participants | Participants |
|
| OG002 | Active Comparator: Counseling and Active Drug Intervention | enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. |
|
|
| Primary | Number of Participants Who Rated the Intervention Acceptable | Acceptability will be determined by the number of patients rating the intervention usefulness in the experimental and control arms on a 7-point Likert scale, where 1=extremely useless and 7=extremely useful. | The primary outcome was defined as acceptability across the entire sample. | Posted | Count of Participants | Participants | Approximately 8 weeks |
|
|
|
| Secondary | Number of Participants With Validated Cessation | Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention. | Only one participant in the "Active Comparator" arm completed the study. | Posted | Count of Participants | Participants | 1 week post-intervention |
|
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Placebo Comparator: Counseling and Placebo Drug Intervention | Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages Counseling and placebo drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Active Comparator: Counseling and Active Drug Intervention | Enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D005159 | Health Care Facilities Workforce and Services |