Trial · NCT00606892

Varenicline and Nicotine Interactions in Humans (VA)

NCT00606892, Not applicable, Completed, Yale University; results first posted 2014-09-25

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Varenicline and Nicotine Interactions in Humans (VA). Trials, record NCT00606892. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00606892

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Varenicline and Nicotine Interactions in Humans (VA)
NCT number: NCT00606892
Status: Completed
Phases: Not applicable
Enrollment: 37 participants, actual
Lead sponsor: Yale University
Conditions: Smoking Cessation
Interventions: Varenicline, Placebo, IV Nic
First posted: 2008-02-05
Last updated: 2014-09-25
Results first posted: 2014-09-25

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Subjective Responses to Intravenous Nicotine	30 minutes after each nicotine infusion	The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from "not at all" (a score of 0) to "extremely" with a maximum score of 100.
Secondary	Mean Reaction Time (RT) on Modified Stroop Task.	pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)	A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).
Secondary	Cotinine Levels	Before each laboratory session on day 5	Subject Cotinine Levels before each laboratory session.
Secondary	Heart Rate	30 minutes after each nicotine infusion	The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.
Secondary	Changes in Systolic and Diastolic Blood Pressure	30 minutes after each nicotine infusion	The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Mean Reaction Time (RT) on Modified Stroop Task.	pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)	Data from all subjects who completed both experimental sessions (nicotine infusion after 4 days of placebo and also 4 days of varneicline, n=12) are presented. RT's \< 100 ms, or \> 1501 ms were excluded from the analysis (\>3 SD's of the mean). The data presented are the mean RT's to identifying word colors under each treatment condition.	milliseconds	MEAN
SECONDARY	Cotinine Levels	Before each laboratory session on day 5	Subjects finishing the complete study. (n=12)	ng/mL	MEAN
PRIMARY	Subjective Responses to Intravenous Nicotine	30 minutes after each nicotine infusion	All participants who complete all interventions.	millimeters	MEAN
SECONDARY	Heart Rate	30 minutes after each nicotine infusion	Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).	beats per minute	MEAN
SECONDARY	Changes in Systolic and Diastolic Blood Pressure	30 minutes after each nicotine infusion	Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).	mm Hg	MEAN

Source ClinicalTrials.gov

Results by group78

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Reaction Time (RT) on Modified Stroop Task.	Placebo, Pre-Nicotine	Smoking Block	722.3	Standard Deviation 131.3	milliseconds
Mean Reaction Time (RT) on Modified Stroop Task.	Placebo, Post-Nicotine	Smoking Block	693.1	Standard Deviation 129.4	milliseconds
Mean Reaction Time (RT) on Modified Stroop Task.	Varenicline, Pre-Nicotine	Smoking Block	660.1	Standard Deviation 137.8	milliseconds
Mean Reaction Time (RT) on Modified Stroop Task.	Varenicline, Post-Nicotine	Smoking Block	624.2	Standard Deviation 100.1	milliseconds
Mean Reaction Time (RT) on Modified Stroop Task.	Placebo, Pre-Nicotine	Neutral Block- Smoking Cue	702.3	Standard Deviation 148.6	milliseconds
Mean Reaction Time (RT) on Modified Stroop Task.	Placebo, Post-Nicotine	Neutral Block- Smoking Cue	686.7	Standard Deviation 134.1	milliseconds
Mean Reaction Time (RT) on Modified Stroop Task.	Varenicline, Pre-Nicotine	Neutral Block- Smoking Cue	652.1	Standard Deviation 115.5	milliseconds
Mean Reaction Time (RT) on Modified Stroop Task.	Varenicline, Post-Nicotine	Neutral Block- Smoking Cue	618.6	Standard Deviation 104.7	milliseconds
Mean Reaction Time (RT) on Modified Stroop Task.	Placebo, Pre-Nicotine	Negative Affect block	679.0	Standard Deviation 104.1	milliseconds
Mean Reaction Time (RT) on Modified Stroop Task.	Placebo, Post-Nicotine	Negative Affect block	641.3	Standard Deviation 114.9	milliseconds

1 to 10 of 78Source ClinicalTrials.gov

See all 78 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Adaptation	STARTED	Placebo First, Then Varenicline	9
Adaptation	STARTED	Varenicline First, Then Placebo	8
Adaptation	COMPLETED	Placebo First, Then Varenicline	9
Adaptation	COMPLETED	Varenicline First, Then Placebo	8
Adaptation	NOT COMPLETED	Placebo First, Then Varenicline	0
Adaptation	NOT COMPLETED	Varenicline First, Then Placebo	0
First Intervention	STARTED	Placebo First, Then Varenicline	9
First Intervention	STARTED	Varenicline First, Then Placebo	8
First Intervention	COMPLETED	Placebo First, Then Varenicline	8
First Intervention	COMPLETED	Varenicline First, Then Placebo	4

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo First, Then Varenicline, First Intervention
Total, all-cause mortality	Varenicline First, Then Placebo, First Intervention
Total, all-cause mortality	Adaptation - Placebo First, Then Varenicline
Total, all-cause mortality	Adaptation - Varenicline First, Then Placebo
Total, all-cause mortality	Placebo First, Then Varenicline, Second Intervention
Total, all-cause mortality	Varenicline First, Then Placebo, Second Intervention
Total, other adverse events	Placebo First, Then Varenicline, First Intervention	0	9
Total, other adverse events	Varenicline First, Then Placebo, First Intervention	0	8
Total, other adverse events	Adaptation - Placebo First, Then Varenicline	0	9
Total, other adverse events	Adaptation - Varenicline First, Then Placebo	0	8

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19693492	RESULT

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DA014537	Progestrone and the Effects of Nicotine	SOFUOGLU, MEHMET	YALE UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2003 to 2006

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Stroop Color-Word Test	Secondary outcome

Source ConductCognition

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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