Nicotine DependencePhase 4NCT00948155
Measuring Smoking Behaviors While Using Varenicline
A Phase 4 study testing Varenicline in people with Nicotine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tobacco Use Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Assessment of Smoking Topography and Behaviors During Response to Varenicline
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.
Read the detailed description
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.
- Conditions
- Nicotine Dependence
- Being tested
- Varenicline
- Keywords
- smoking, nicotine, varenicline
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Varenicline |
| 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' Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Days 1, 7, 21 of each of two 21 day study periods
Daily Cigarette Consumption
Average of the number of cigarettes smoked per day
Measured: Two 21 day study periods
Secondary outcomes (5)
Total Nicotine Metabolites From Urine Samples
Total urinary metabolites from urine samples collected at Day 1 and Day 21
Measured: Samples from Day 1 and Day 21 of two 21 day Periods
Nicotine Levels From Urine Samples
Nicotine levels from urine samples collected at Day 1 and Day 21.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Andrew Strasser, University of Pennsylvania
- Investigators
- Andrew Strasser, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948155
- Sponsor's protocol ID
- 808930
- Status last verified
- Dec 2014
- First submitted
- 28 Jul 2009
- Last updated
- 16 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22695488
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Smoking Topography and Behaviors During Response to Varenicline
- ClinicalTrials.gov ID
- NCT00948155
- Acronym / sponsor ID
- 808930
- Conditions
- Nicotine Dependence
- Keywords
- smoking, nicotine, varenicline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Posted 16 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline before placebo | Experimental | Drug: VareniclineDrug (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. |
| Placebo then Varenicline | Experimental | Drug: VareniclinePlacebo: 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' |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: ChantixIntervention 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. | Drug | Placebo then Varenicline, Varenicline before placebo |
Primary outcome
Smoking Topography: Total Puff Volume
Time frame: 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.
The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.
Time frame: Days 1, 7, 21 of each of two 21 day study periods
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.
Daily Cigarette Consumption
Time frame: Two 21 day study periods
Average of the number of cigarettes smoked per day
5 secondary outcomes
Total Nicotine Metabolites From Urine Samples
Time frame: Samples from Day 1 and Day 21 of two 21 day Periods
Nicotine Levels From Urine Samples
Time frame: Samples from Day 1 and Day 21 of two 21 day Periods
Cotinine Levels From Urine Samples
Time frame: Samples from Day 1 and Day 21 of two 21 day Periods
Carbon Monoxide Levels
Time frame: Samples from Day 1 and Day 21 of two 21 day Periods
Subjective Measures to Assess Smoking Urges
Time frame: Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22695488Ashare 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Strasser, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline in people with Nicotine Dependence, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Topography: Total Puff Volume (time frame: Days 1-21 of each of 2 study periods). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.