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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA038775 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The objective of this study is to determine whether treatment with random nicotine delivery via a nicotine film both before and after the target quit date will facilitate smoking cessation relative to treatment with steady state delivery or placebo.
The investigators hypothesize that smoking cessation will be greater in subjects assigned to a random nicotine delivery regimen (as compared to those assigned to a steady state or placebo regimen). The nicotine film product is not part of the standard of care and is not available in non-investigational settings in the United States.
This project is a prospective parallel-group, randomized, double-blind, placebo-controlled study in which 45 current cigarette smokers who are interested in quitting will be randomly allocated to one of three possible nicotine film treatment regimens:
Prior to assignment in one of the above treatment groups, all participants will take part in a 1-week baseline period to assess normal smoking behavior and nicotine dependence. Following randomization to their assigned treatment group at Visit 2, participants will be instructed to smoke cigarettes as they feel necessary over the next two weeks while using the nicotine films as directed (i.e., one film every 3-4 hours for a total of four films per day). After two weeks of pre-cessation treatment, participants will be asked completely cease cigarette smoking and to only use their assigned nicotine films as directed. Participants will be supported in their quitting efforts with regular contacts both in person at the Penn State Milton S. Hershey Medical Center and over the phone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Random Nicotine Delivery | Experimental | One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks. |
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| Steady State Nicotine Delivery | Active Comparator | One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. |
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| Placebo Control | Placebo Comparator | One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Film | Drug | Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Cigarettes Smoked Per Day (CPD) | CPD is measured with the use of daily cigarette logs which are completed daily by participants and returned to the study center at each visit. The CPD measure will be the average of the past 7 days. | Baseline and 4 weeks after Target Quit Date |
| Change in Exhaled Carbon Monoxide (CO) Measurement | Mean change in exhaled CO (parts per million [ppm]) | Baseline and 4 weeks after Target Quit Date |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Total Score | The QSU-Brief, with a possible total score range of 10 to 70, is an instrument used to measure cigarette craving. A score of 10 on this scale indicates very low cigarette craving, while a score of 70 indicates very high cigarette craving. | Baseline and 4 weeks after Target Quit Date |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia S Grigson, PhD | Penn State College of Medicine | Principal Investigator |
| Jonathan Foulds, PhD | Penn State College of Medicine | Principal Investigator |
| Christopher Sciamanna, MD | Penn State College of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Random Nicotine Delivery | One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
| FG001 | Steady State Nicotine Delivery | One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
| FG002 | Placebo Control | One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Random Nicotine Delivery | One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
| 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 |
| 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 | Change in Number of Cigarettes Smoked Per Day (CPD) | CPD is measured with the use of daily cigarette logs which are completed daily by participants and returned to the study center at each visit. The CPD measure will be the average of the past 7 days. | Posted | Mean | Standard Deviation | cigarettes per day | Baseline and 4 weeks after Target Quit Date |
|
Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
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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 | Random Nicotine Delivery | One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Sue Grigson | Penn State College of Medicine | 717-531-5772 | pgrigsonkennedy@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2019 | Nov 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000073865 | Cigarette Smoking |
| D012907 | Smoking |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
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| Change in Fagerstrom Test for Nicotine Dependence (FTND) Total Score | Nicotine dependence will be assessed via the FTND, a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence). | Baseline and 4 weeks after Target Quit Date |
| Subjective Ratings Scale for Nicotine Film Use | The scale is comprised of 21 items. Each item is rated on a scale 1-7, where 1 is equal to not at all and 7 is equal to extremely. The total score is the average score of all 21 items. The total score ranges from 1-7. | 4 weeks after Target Quit Date |
| Side Effects From Nicotine Film Use | Total score ranges from 0 - 36 with lower scores indicating lesser side effects. | 4 weeks after Target Quit Date |
| BG001 | Steady State Nicotine Delivery | One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
| BG002 | Placebo Control | One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
| BG003 | Total | Total of all reporting groups |
| 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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| Region of Enrollment | Number | participants |
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| Cigarettes Per Day | Mean | Standard Deviation | Cigarettes per day |
|
| Fagerstrom Test for Nicotine Dependence Total Score | The Fagerstrom Test for Nicotine Dependence is a 6 item questionnaire to assess dependence on cigarettes. The total score is a sum of each item's score. The range of the total score is 1-10. Scores indicate the following: 1-2 = very low dependence; 3-4 = low dependence; 5 = moderate dependence; 6-7 = high dependence; 8+ = very high dependence. | Mean | Standard Deviation | Scores on a scale |
|
| OG001 | Steady State Nicotine Delivery | One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
| OG002 | Placebo Control | One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. |
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| Primary | Change in Exhaled Carbon Monoxide (CO) Measurement | Mean change in exhaled CO (parts per million [ppm]) | Posted | Mean | Standard Deviation | parts per million | Baseline and 4 weeks after Target Quit Date |
|
|
|
|
| Secondary | Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Total Score | The QSU-Brief, with a possible total score range of 10 to 70, is an instrument used to measure cigarette craving. A score of 10 on this scale indicates very low cigarette craving, while a score of 70 indicates very high cigarette craving. | Posted | Mean | Standard Deviation | QSU Total Score | Baseline and 4 weeks after Target Quit Date |
|
|
|
|
| Secondary | Change in Fagerstrom Test for Nicotine Dependence (FTND) Total Score | Nicotine dependence will be assessed via the FTND, a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence). | Posted | Mean | Standard Deviation | FTND Total Score | Baseline and 4 weeks after Target Quit Date |
|
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| Secondary | Subjective Ratings Scale for Nicotine Film Use | The scale is comprised of 21 items. Each item is rated on a scale 1-7, where 1 is equal to not at all and 7 is equal to extremely. The total score is the average score of all 21 items. The total score ranges from 1-7. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after Target Quit Date |
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| Secondary | Side Effects From Nicotine Film Use | Total score ranges from 0 - 36 with lower scores indicating lesser side effects. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after Target Quit Date |
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| 0 |
| 15 |
| 0 |
| 15 |
| 9 |
| 15 |
| EG001 | Steady State Nicotine Delivery | One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. | 0 | 15 | 0 | 15 | 11 | 15 |
| EG002 | Placebo Control | One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. | 0 | 15 | 0 | 15 | 8 | 15 |
| Hiccups | Gastrointestinal disorders | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Other | Investigations | Systematic Assessment |
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| D003192 |
| Compulsive Behavior |
| D007175 | Impulsive Behavior |