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| ID | Type | Description | Link |
|---|---|---|---|
| 106842 | Other Identifier | USF IRB |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This was not a quit smoking treatment study, and participants were not asked or required to stop smoking while in this study.
We proposed the following primary hypotheses:
A final sample of 100 non-treatment seeking daily smokers were recruited from the Tampa-St. Petersburg-Clearwater Metropolitan Area via paid advertisements in, and press releases to, local newspapers, as well as targeted outdoor advertising via flyers (e.g., on public transportation).
Following the screening session, participants were randomly assigned to receive either varenicline or placebo medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline | Active Comparator | For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15. |
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| Placebo | Placebo Comparator | Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | Participants in this group received varenicline according to the schedule in the Arm Description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tonic Craving Score (QSU) Based on Self Reports | Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues. | 3 weeks per participant |
| Cue-provoked Cravings | Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?" | 3 weeks per participant |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Topography - Number of Puffs on a Cigarette | # Puffs = total number of puffs taken at Assessment Session. | 3 weeks per participant |
| A Measure of the Subjective Expected Value of a Cigarette |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Brandon, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
Participants completed a baseline evaluation including screening for inclusion and exclusion criteria, a medical evaluation, basic metabolic panel and pregnancy test for females. Participants who met all of the inclusion criteria were scheduled for the assessment sessions.
To achieve a sample size of 100 following attrition, we screened 573 smokers from the community and randomized 100 non-treatment seeking daily smokers to the two conditions. Smokers who were using other smoking cessation medications, or who had current mood or psychotic disorders were excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15. |
| FG001 | Placebo | Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15. |
| BG001 | Placebo |
| 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, Categorical | Count of Participants |
| 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 | Tonic Craving Score (QSU) Based on Self Reports | Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues. | Per Protocol | Posted | Mean | Standard Error | Scores on a scale | 3 weeks per participant |
|
3 weeks per participant
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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 | Varenicline | For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas H. Brandon, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | 813-745-1750 | thomas.brandon@moffitt.org |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description. |
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The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).
| 3 weeks per participant |
Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Placebo | Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15. |
|
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| Secondary | Smoking Topography - Number of Puffs on a Cigarette | # Puffs = total number of puffs taken at Assessment Session. | Per Protocol | Posted | Mean | Standard Error | Puffs on a Cigarette | 3 weeks per participant |
|
|
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| Primary | Cue-provoked Cravings | Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?" | Per Protocol | Posted | Mean | Standard Error | Scores on a scale | 3 weeks per participant |
|
|
|
| Secondary | A Measure of the Subjective Expected Value of a Cigarette | The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007). | Per Protocol | Posted | Mean | Standard Error | Dollars | 3 weeks per participant |
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| 0 |
| 82 |
| 0 |
| 82 |
| EG001 | Placebo | Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15. | 0 | 81 | 0 | 81 |
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| D011810 | Quinoxalines |