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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.
This study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline. Behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes. The primary hypothesis for the study is to observe decreases in smoking topography, an objective measure of smoking behavior or puffing, on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We will also examine puffing and nicotine cigarette choices during lab visits at baseline, and Days 7 and 21. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus potentially increasing the efficacy of varenicline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline before placebo | Experimental | Drug (Varenicline (Chantix)): Placebo Intervention to be administered is: participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. |
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| Placebo then Varenicline | Experimental | Placebo: Drug Varenicline (Chantix) Intervention to be administered is: participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Intervention 'Drug (Varenicline (Chantix)): Placebo' |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Topography: Total Puff Volume | Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors. | Days 1-21 of each of 2 study periods |
| The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette. | Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods. | Days 1, 7, 21 of each of two 21 day study periods |
| Daily Cigarette Consumption | Average of the number of cigarettes smoked per day | Two 21 day study periods |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nicotine Metabolites From Urine Samples | Total urinary metabolites from urine samples collected at Day 1 and Day 21 | Samples from Day 1 and Day 21 of two 21 day Periods |
| Nicotine Levels From Urine Samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Strasser, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tobacco Use Research Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22695488 | Result | Ashare RL, Tang KZ, Mesaros AC, Blair IA, Leone F, Strasser AA. Effects of 21 days of varenicline versus placebo on smoking behaviors and urges among non-treatment seeking smokers. J Psychopharmacol. 2012 Oct;26(10):1383-90. doi: 10.1177/0269881112449397. Epub 2012 Jun 13. |
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48 participants signed consents and were enrolled in the study. Medical clearance was achieved by 41; 29 returned for the first laboratory visit which is the first day drug/placebo was administered. The 12 who did not return for the Day 1 visit were not included further in the study.
There was a minimum 14 washout period between drug conditions.
Recruitment occurred in a research laboratory in a school of medicine. Dates of recruitment: first participant first visit March 31, 2009; last participants last visit December 02, 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Varenicline | Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21. |
| FG001 | Varenicline Before Placebo | Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention 21 Days |
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| Washout 14 Days |
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| Second Intervention 21 Days |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then Varenicline | Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Smoking Topography: Total Puff Volume | Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors. | All those participants who completed both study periods were included in the analysis. | Posted | Mean | Standard Error | milliliters | Days 1-21 of each of 2 study periods |
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Systematic assessment of adverse events occurred at baseline, Days 1, 7, 21 when participant is present in research center.
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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 | Placebo Then Varenicline | Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21. |
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Attrition rates were high. The final sample consisted primarily of Caucasian males, which may limit the generalizability of the present findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew A. Strasser, Ph.D., Associate Professor | University of Pennsylvania | 215 746 5788 | strasse3@mail.med.upenn.edu |
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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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Nicotine levels from urine samples collected at Day 1 and Day 21.
| Samples from Day 1 and Day 21 of two 21 day Periods |
| Cotinine Levels From Urine Samples | Cotinine levels from urine samples collected at Day 1 and Day 21. | Samples from Day 1 and Day 21 of two 21 day Periods |
| Carbon Monoxide Levels | Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure. | Samples from Day 1 and Day 21 of two 21 day Periods |
| Subjective Measures to Assess Smoking Urges | Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit. In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). The values are then summed to create a single total score. Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect. Internal consistency for each scale across all time points was high (Cronbach's α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively). Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke. Data was collected at each time point but outcome measure of interest is end of period. | Days 21 of each of the two 21-day study periods, range 1(low)-7(high) |
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| BG001 |
| Varenicline Before Placebo |
Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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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 | Varenicline Before Placebo | Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21. |
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| Primary | The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette. | Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods. | All participants who completed the task were included in the analysis | Posted | Mean | Standard Error | number of puffs chosen of a maximum 24 | Days 1, 7, 21 of each of two 21 day study periods |
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| Primary | Daily Cigarette Consumption | Average of the number of cigarettes smoked per day | Posted | Mean | Standard Error | number of cigarettes smoked per day | Two 21 day study periods |
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| Secondary | Total Nicotine Metabolites From Urine Samples | Total urinary metabolites from urine samples collected at Day 1 and Day 21 | Subjects who completed both 21 day placebo and drug periods. | Posted | Mean | Standard Deviation | micromolar | Samples from Day 1 and Day 21 of two 21 day Periods |
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| Secondary | Nicotine Levels From Urine Samples | Nicotine levels from urine samples collected at Day 1 and Day 21. | Subjects who completed both 21 day placebo and drug periods. | Posted | Mean | Standard Deviation | micromolar | Samples from Day 1 and Day 21 of two 21 day Periods |
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| Secondary | Cotinine Levels From Urine Samples | Cotinine levels from urine samples collected at Day 1 and Day 21. | Subjects who completed both 21 day placebo and drug periods. | Posted | Mean | Standard Deviation | micromolar | Samples from Day 1 and Day 21 of two 21 day Periods |
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| Secondary | Carbon Monoxide Levels | Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure. | Subjects who completed both 21 day placebo and drug periods. | Posted | Mean | Standard Error | parts per million | Samples from Day 1 and Day 21 of two 21 day Periods |
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| Secondary | Subjective Measures to Assess Smoking Urges | Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit. In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). The values are then summed to create a single total score. Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect. Internal consistency for each scale across all time points was high (Cronbach's α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively). Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke. Data was collected at each time point but outcome measure of interest is end of period. | Subjects who completed both 21 day placebo and drug periods. | Posted | Mean | Standard Deviation | units on a scale | Days 21 of each of the two 21-day study periods, range 1(low)-7(high) |
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| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Varenicline Before Placebo | Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21. | 0 | 15 | 0 | 15 |
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| D011810 | Quinoxalines |
| Factor 2 Day 1 |
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| Factor 2 Day 21 |
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