- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00948155
Measuring Smoking Behaviors While Using Varenicline
Assessment of Smoking Topography and Behaviors During Response to Varenicline
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Tobacco Use Research Center
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- self report minimum 10 daily cigarettes
- self report smoking every day past 5 years
- between the ages 21-65
- self report intention to try to quit smoking in the next 6 months
Exclusion Criteria:
- self reported use of any nicotine-containing products other than non-menthol cigarettes
- self reported history or current treatment of substance abuse (other than nicotine dependence)
- self reported alcohol use greater than 25 standard drinks per week;
- currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
- self reported history or current diagnosis of any Axis 1 disorders except past depression
- self reported serious or unstable disease within past year
- self reported history of epilepsy or seizure disorder;
- self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
- self reported kidney function impairment
- any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
- less than 5 years of daily smoking
- any medical condition or concomitant medication that could compromise participant safety or treatment
- provide a baseline carbon monoxide (CO) reading < 10 ppm
- self reported use of non filtered cigarettes
- inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Varenicline before placebo
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. |
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.
Andra namn:
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Experimentell: Placebo then Varenicline
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' |
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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Smoking Topography: Total Puff Volume
Tidsram: Days 1-21 of each of 2 study periods
|
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
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The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.
Tidsram: Days 1, 7, 21 of each of two 21 day study periods
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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.
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Days 1, 7, 21 of each of two 21 day study periods
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Daily Cigarette Consumption
Tidsram: Two 21 day study periods
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Average of the number of cigarettes smoked per day
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Two 21 day study periods
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Total Nicotine Metabolites From Urine Samples
Tidsram: Samples from Day 1 and Day 21 of two 21 day Periods
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Total urinary metabolites from urine samples collected at Day 1 and Day 21
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Samples from Day 1 and Day 21 of two 21 day Periods
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Nicotine Levels From Urine Samples
Tidsram: Samples from Day 1 and Day 21 of two 21 day Periods
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Nicotine levels from urine samples collected at Day 1 and Day 21.
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Samples from Day 1 and Day 21 of two 21 day Periods
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Cotinine Levels From Urine Samples
Tidsram: Samples from Day 1 and Day 21 of two 21 day Periods
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Cotinine levels from urine samples collected at Day 1 and Day 21.
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Samples from Day 1 and Day 21 of two 21 day Periods
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Carbon Monoxide Levels
Tidsram: Samples from Day 1 and Day 21 of two 21 day Periods
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Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions.
Alveolar carbon monoxide is a validated assessment of smoke exposure.
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Samples from Day 1 and Day 21 of two 21 day Periods
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Subjective Measures to Assess Smoking Urges
Tidsram: Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
|
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.
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Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
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Studieavstämningsdatum
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Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 808930
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