Trial Outcomes & Findings for Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes (NCT NCT04310735)

Last Updated: 2025-03-07

Results Overview

Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging (fMRI) was analyzed as participants were presented with smoking-related and neutral cues. Following preprocessing with fMRIPrep (version 20.2.7), the FMRI Expert Analysis Tool (FEAT) from FMRIB's Software Library (FSL; version 6.0.7.4) was used to characterize brain activation differences in response to smoking-related versus neutral cues. Contrast of parameter estimate (COPE) values were calculated for each participant, and these COPE values were then extracted for two a priori regions of interest (ROIs) to compare activation patterns between the groups. Larger COPE values indicate greater differences in brain activation between smoking-related and neutral cues,

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

Approximately Day 7 (Visit 2)

Results posted on

2025-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Expect-Yes Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Overall Study STARTED	14	13	35
Overall Study COMPLETED	13	9	27
Overall Study NOT COMPLETED	1	4	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Expect-Yes Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Overall Study Withdrawal by Subject	1	3	8
Overall Study Equipment malfunction	0	1	0

Baseline Characteristics

Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Expect-Yes n=14 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=13 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing n=35 Participants Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants	62 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	34.8 years STANDARD_DEVIATION 9.6 • n=5 Participants	31.7 years STANDARD_DEVIATION 9.4 • n=7 Participants	28.5 years STANDARD_DEVIATION 7.3 • n=5 Participants	30.5 years STANDARD_DEVIATION 8.6 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	23 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	33 Participants n=5 Participants	57 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants	39 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	14 participants n=5 Participants	13 participants n=7 Participants	35 participants n=5 Participants	62 participants n=4 Participants
Annual Household Income Less than $10,000	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Annual Household Income Less than $15,000 ($10,000 to less than $15,000)	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Annual Household Income Less than $20,000 ($15,000 to less than $20,000)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Annual Household Income Less than $25,000 ($20,000 to less than $25,000)	2 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants
Annual Household Income Less than $35,000 ($25,000 to less than $35,000)	4 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	17 Participants n=4 Participants
Annual Household Income Less than $50,000 ($35,000 to less than $50,000)	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Annual Household Income Less than $75,000 ($50,000 to less than $75,000)	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Annual Household Income $75,000 or more	2 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants	12 Participants n=4 Participants
Annual Household Income Not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Approximately Day 7 (Visit 2)

Population: Participants who completed the scan session and who provided usable brain imaging data were included in analyses. Participants in the Behavioral Testing Arm did not complete a scan session and were not assessed for brain activation during smoking-related and neutral cues.

Outcome measures

Outcome measures
Measure	Experimental: Expect-Yes n=9 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=11 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Brain Activation During Smoking-related and Neutral Cues Ventromedial prefrontal cortex ROI (10-mm sphere centered at MNI x = -1, y = 46, z = -7)	5.8 contrast of parameter estimate Standard Error 2.4	-1.6 contrast of parameter estimate Standard Error 3.8	—
Brain Activation During Smoking-related and Neutral Cues Dorsal anterior cingulate cortex ROI (10-mm sphere centered at MNI x = -2, y = 10, z = 38)	1.1 contrast of parameter estimate Standard Error 3.4	-4.2 contrast of parameter estimate Standard Error 2.8	—

PRIMARY outcome

Timeframe: Approximately Day 7 (Visit 2)

Population: Participants who provided usable facial expression data were included in analyses.

Subjective affective responses were measured by using FaceReader software (version 9.1.7) to code the valence (positive or negative) of facial movements associated with emotional expression during the presentation of smoking-related and neutral cues. Possible values for valence range from -1 to 1, with higher values indicating greater positive affect,

Outcome measures

Outcome measures
Measure	Experimental: Expect-Yes n=9 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=11 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing n=9 Participants Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues Valence during neutral cues	-.27 units on a scale Standard Error .10	-.25 units on a scale Standard Error .09	-.18 units on a scale Standard Error .08
Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues Valence during smoking-related cues	-.27 units on a scale Standard Error .09	-.24 units on a scale Standard Error .09	-.23 units on a scale Standard Error .08

SECONDARY outcome

Timeframe: Approximately Day 7 (Visit 2)

Population: Participants who provided usable ratings data were included in analyses.

Participants rated their urge to smoke during the presentation of smoking-related and neutral cues on a scale ranging from 1 (not at all) to 9 (extremely), with higher scores indicating a stronger desire to smoke. For each type of cue (smoking-related and neutral), repeated ratings were obtained across multiple trials. To report a single value for each Arm/Group, the ratings were averaged across all trials for each cue type.

Outcome measures

Outcome measures
Measure	Experimental: Expect-Yes n=9 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=11 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing n=9 Participants Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Self-reported Urge to Smoke During Smoking-related and Neutral Cues Self-reported urge during smoking-related cues	7.4 units on a scale Standard Error 0.2	7.1 units on a scale Standard Error 0.6	6.3 units on a scale Standard Error 0.7
Self-reported Urge to Smoke During Smoking-related and Neutral Cues Self-reported urge during neutral cues	4.9 units on a scale Standard Error 0.6	5.0 units on a scale Standard Error 0.6	3.7 units on a scale Standard Error 0.9

SECONDARY outcome

Timeframe: Approximately Day 7 (Visit 2)

Population: Participants who provided usable ratings data were included in analyses.

Participants rated their current affect during the presentation of smoking-related and neutral cues on a scale ranging from 1 (very negative) to 9 (very positive), with higher scores indicating greater positive affect. For each type of cue (smoking-related and neutral), repeated ratings were obtained across multiple trials. To report a single value for each Arm/Group, the ratings were averaged across all trials for each cue type.

Outcome measures

Outcome measures
Measure	Experimental: Expect-Yes n=9 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=11 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing n=9 Participants Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Self-reported Affect During Smoking-related and Neutral Cues Self-reported affect during smoking-related cues	6.1 units on a scale Standard Error 0.3	5.5 units on a scale Standard Error 0.3	5.1 units on a scale Standard Error 0.7
Self-reported Affect During Smoking-related and Neutral Cues Self-reported affect during neutral cues	5.9 units on a scale Standard Error 0.2	5.4 units on a scale Standard Error 0.3	5.9 units on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Day 1 (Visit 1)

Population: Only participants with usable data for the specified outcome were included in the analysis (i.e., those with missing data were excluded).

Participants' level of nicotine dependence was assessed using the total score on the Fagerström Test for Nicotine Dependence to help characterize the sample. Possible scores on the Fagerström Test for Nicotine Dependence range from 0 to 10, with higher scores indicating greater nicotine dependence.

Outcome measures

Outcome measures
Measure	Experimental: Expect-Yes n=14 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=13 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing n=17 Participants Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Nicotine Dependence	3.8 units on a scale Standard Error 0.6	4.1 units on a scale Standard Error 0.6	4.4 units on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Approximately Day 7 (Visit 2)

Population: Participants who completed the scan session and who provided usable brain imaging data were included in analyses (i.e., those with missing data or unusable data due to quality issue such as excessive head motion were excluded). Participants in the Behavioral Testing Arm did not complete a scan session and were not assessed for brain activation during positive and negative emotion cues.

Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging (fMRI) was analyzed as participants were presented with cues designed to elicit positive and negative emotion. Following preprocessing with fMRIPrep (version 20.2.7), the FMRI Expert Analysis Tool (FEAT) from FMRIB's Software Library (FSL; version 6.0.7.4) was used to characterize brain activation in response to positive and negative emotion cues. Contrast of parameter estimate (COPE) values were calculated for each participant, and these COPE values were then extracted for two a priori regions of interest (ROIs) to compare activation patterns between the groups. Larger COPE values indicate greater differences in brain activation between positive and negative emotion cues.

Outcome measures

Outcome measures
Measure	Experimental: Expect-Yes n=9 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=12 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Brain Activation During Positive and Negative Emotion Cues Ventromedial prefrontal cortex ROI (10-mm sphere centered at MNI x = -1, y = 46, z = -7)	2.4 contrast of parameter estimate Standard Error 5.9	5.5 contrast of parameter estimate Standard Error 2.8	—
Brain Activation During Positive and Negative Emotion Cues Dorsal anterior cingulate cortex ROI (10-mm sphere centered at MNI x = -2, y = 10, z = 38)	-10.8 contrast of parameter estimate Standard Error 4.5	-2.2 contrast of parameter estimate Standard Error 5.2	—

SECONDARY outcome

Timeframe: Approximately Day 7 (Visit 2)

Population: Participants who provided usable facial expression data were included in analyses.

Subjective affective responses were measured by using FaceReader software (version 9.1.7) to code the valence (positive or negative) of facial movements associated with emotional expression during the presentation of cues designed to elicit positive and negative emotion. Possible values for valence range from -1 to 1, with higher values indicating greater positive affect,

Outcome measures

Outcome measures
Measure	Experimental: Expect-Yes n=9 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=12 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing n=19 Participants Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues Valence during positive emotion cues	-.19 units on a scale Standard Error .10	-.17 units on a scale Standard Error .10	.03 units on a scale Standard Error .05
Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues Valence during negative emotion cues	-.24 units on a scale Standard Error .10	-.25 units on a scale Standard Error .09	-.12 units on a scale Standard Error .04

SECONDARY outcome

Timeframe: Approximately Day 7 (Visit 2)

Population: Participants who provided usable ratings data were included in analyses. Participants in the Behavioral Testing Arm were not presented with cues designed to elicit positive and negative emotion (they were only presented with smoking-related and neutral cues) and therefore did not provide data for this secondary outcome.

Participants rated their urge to smoke during the presentation of cues designed to elicit positive and negative emotions on a scale ranging from 1 (not at all) to 9 (extremely), with higher scores indicating a stronger desire to smoke. For each type of cue (positive and negative emotion), repeated ratings were obtained across multiple trials. To report a single value for each Arm/Group, the ratings were averaged across all trials for each cue type.

Outcome measures

Outcome measures
Measure	Experimental: Expect-Yes n=9 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=12 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Self-reported Urge to Smoke During Positive and Negative Emotion Cues Self-reported urge during positive emotion cues	3.0 units on a scale Standard Error .3	4.0 units on a scale Standard Error .6	—
Self-reported Urge to Smoke During Positive and Negative Emotion Cues Self-reported urge during negative emotion cues	6.1 units on a scale Standard Error .5	5.8 units on a scale Standard Error .4	—

SECONDARY outcome

Timeframe: Approximately Day 7 (Visit 2)

Population: Participants who provided usable ratings data were included in analyses.

Participants rated their current affect during the presentation of cues designed to elicit positive and negative emotion on a scale ranging from 1 (very negative) to 9 (very positive), with higher scores indicating greater positive affect. For each type of cue (positive and negative emotion), repeated ratings were obtained across multiple trials. To report a single value for each Arm/Group, the ratings were averaged across all trials for each cue type.

Outcome measures

Outcome measures
Measure	Experimental: Expect-Yes n=9 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Experimental: Expect-No n=12 Participants Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Verbal smoking expectancy manipulation: Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioral Testing n=19 Participants Participants asked to complete behavioral testing only during experimental session for initial piloting, to allow progress toward the aims of the project while research was initially shut down and then subsequently restricted due to the COVID-19 pandemic, and to troubleshoot technical challenges.
Self-reported Affect During Positive and Negative Emotion Cues Self-reported affect during negative emotion cues	2.8 units on a scale Standard Error .3	2.9 units on a scale Standard Error .3	3.7 units on a scale Standard Error .3
Self-reported Affect During Positive and Negative Emotion Cues Self-reported affect during positive emotion cues	7.6 units on a scale Standard Error .2	6.7 units on a scale Standard Error .3	6.4 units on a scale Standard Error .3

Adverse Events

Experimental: Expect-Yes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental: Expect-No

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen Wilson

The Pennsylvania State University

Phone: 8148656219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place