An interventional study of Varenicline and Placebo in Nicotine Dependence, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-10.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.
Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final eligibility. Following a medication run-up and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan while performing attention, working memory and emotion tasks). After a 14 to 21-day washout period the study procedures will be repeated with placebo (order of study medication counterbalanced). After completion of both study periods, all participants will be offered a 13-week quit smoking program with varenicline.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 38 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Smoking Behavior
Alcohol/Drug Exclusion Criteria
Medication Exclusion Criteria
Current use or recent discontinuation (within last 14-days) of the following medications:
Any form of anti-psychotic medications that includes:
Medical Exclusion Criteria
General Exclusion
Drug: Placebo
Drug: Varenicline
Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily
Also known as: Chantix
Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.
Percent Change BOLD Signal
We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.
Time frame: Day 13
Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time)
We examined the difference in correct reaction time on the N-back task between varenicline and placebo treatment. Models included terms for the main effect of treatment period (varenicline vs. placebo), memory load (0-back, 1-back, 2-back, 3-back) and covariates. We tested for interactions between nicotine dependence severity and treatment.
Time frame: Day 13
Participants were recruited from mass media advertising in the greater Philadelphia area from November 2007 - June 2008.
| Milestone | Placebo First, Then Varenicline | Varenicline First, Then Placebo |
|---|---|---|
| Started | 19 | 19 |
| Completed | 15 | 14 |
| Not completed | 4 | 5 |
| Withdrew: Protocol violation | 2 | 4 |
| Withdrew: Mri scanner technical issue | 1 | 0 |
| Withdrew: Time | 1 | 0 |
| Withdrew: Claustrophobia | 0 | 1 |
| Milestone | Placebo First, Then Varenicline | Varenicline First, Then Placebo |
|---|---|---|
| Started | 15 | 14 |
| Completed | 15 | 12 |
| Not completed | 0 | 2 |
| Withdrew: Protocol violation | 0 | 2 |
| Milestone | Placebo First, Then Varenicline | Varenicline First, Then Placebo |
|---|---|---|
| Started | 15 | 12 |
| Completed | 13 | 9 |
| Not completed | 2 | 3 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Mri data quality | 2 | 2 |
We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.
| BOLD Signal Change (3-back minus 0-back) | Placebo | Varenicline |
|---|---|---|
| Percent Change BOLD Signal | 0.48 ± 0.05 | 0.61 ± 0.03 |
We examined the difference in correct reaction time on the N-back task between varenicline and placebo treatment. Models included terms for the main effect of treatment period (varenicline vs. placebo), memory load (0-back, 1-back, 2-back, 3-back) and covariates. We tested for interactions between nicotine dependence severity and treatment.
| Milliseconds | Placebo | Varenicline |
|---|---|---|
| Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time) | 692.14 ± 128.57 | 637.99 ± 164.30 |
Collected over Day 13. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo First, Then Varenicline | — | 0/19 (0%) | 0/19 (0%) |
| Varenicline First, Then Placebo | — | 0/19 (0%) | 1/19 (5.3%) |
| Event | Placebo First, Then Varenicline | Varenicline First, Then Placebo |
|---|---|---|
| Severe LethargyGeneral disorders | 0/19 | 1/19 |
| Age, Categorical(Participants) | Placebo First, Then Varenicline | Varenicline First, Then Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 19 | 38 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Placebo First, Then Varenicline | Varenicline First, Then Placebo | Total |
|---|---|---|---|
| Mean | 41.05 ± 13.32 | 39.79 ± 12.68 | 40.42 ± 12.84 |
| Sex: Female, Male(Participants) | Placebo First, Then Varenicline | Varenicline First, Then Placebo | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 10 | 9 | 19 |
| Region of Enrollment(participants) | Placebo First, Then Varenicline | Varenicline First, Then Placebo | Total |
|---|---|---|---|
| United States | 19 | 19 | 38 |
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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