Smoking, Tobacco
Conditions
Brief summary
The study will use functional magnetic resonance imaging and facial coding methods to study individuals who smoke cigarettes. Smoking expectancy (the extent to which one perceives an opportunity to smoke a cigarette) will be manipulated using instructions, and the investigators will examine the effects of this manipulation on two primary endpoints under conditions designed to induce an urge to smoke: (1) brain responses measured using fMRI and (2) subjective affective responses measured using facial coding. Secondary endpoints include self-report measures of the desire to smoke and current affect.
Interventions
BEHAVIORALVerbal smoking expectancy manipulation
Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.
Sponsors
National Institute on Drug Abuse (NIDA)
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be between the ages of 21 and 55. * Participants must be right handed. * Participants must be fluent English speakers. * Participants must report smoking at least 6 cigarettes per day continuously for at least the 12 preceding months. * Participants must have a baseline expired air carbon monoxide (CO) exceeding a cutoff based upon prior research in order to verify smoking status.
Exclusion criteria
* Individuals will be excluded if they report that they are actively trying to quit smoking. * Individuals will be excluded if they report that they have had significant cardiovascular disease (such as heart disease, heart attack, stroke, or angina) or respiratory disease (such as asthma, chronic bronchitis, or COPD) during the past year. * Individuals will be excluded if they report that they have used any of the following illicit substances more than 10 times in the previous 30 days: marijuana, cocaine, opiates such as heroin, methadone, benzodiazepines (such as Valium, Xanax), barbiturates, amphetamines, methamphetamines, PCP, LSD or any other hallucinogen. * Individuals will be excluded if they report that they are currently taking prescription medications that previously have been found to affect blood flow responses in the brain. * Individuals will be excluded if they have any known risk from exposure to high-field strength magnetic fields (e.g., pace makers), any irremovable metallic foreign objects in their body (e.g., braces), or a questionable history of metallic fragments that are likely to create artifact on the MRI scans. * Individuals will be excluded if they meet criteria for current dependence on a substance other than nicotine based upon a brief structured interview. * Individuals will be excluded if they report that they are not willing to refrain from using alcohol and recreational drugs for 24 hours and nicotine for 12 hours before the experimental lab visit. * Individuals will be excluded if they currently use nicotine products other than cigarettes (e.g., chewing tobacco, snuff, e-cigarettes, or smoking cessation products). * Individuals will be excluded if they are claustrophobic or are prone to becoming very uncomfortable in confined spaces. * Individuals will be excluded if they report that they exclusively or primarily smoke roll-your-own cigarettes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Activation During Smoking-related and Neutral Cues | Approximately Day 7 (Visit 2) | 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, |
| Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues | Approximately Day 7 (Visit 2) | 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, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Dependence | Day 1 (Visit 1) | 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. |
| Brain Activation During Positive and Negative Emotion Cues | Approximately Day 7 (Visit 2) | 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. |
| Self-reported Urge to Smoke During Smoking-related and Neutral Cues | Approximately Day 7 (Visit 2) | 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. |
| Self-reported Urge to Smoke During Positive and Negative Emotion Cues | Approximately Day 7 (Visit 2) | 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. |
| Self-reported Affect During Positive and Negative Emotion Cues | Approximately Day 7 (Visit 2) | 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. |
| Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues | Approximately Day 7 (Visit 2) | 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, |
| Self-reported Affect During Smoking-related and Neutral Cues | Approximately Day 7 (Visit 2) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 13 |
| 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. | 35 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Equipment malfunction | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 8 |
Baseline characteristics
| Characteristic | Experimental: Expect-Yes | Experimental: Expect-No | Behavioral Testing | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 13 Participants | 35 Participants | 62 Participants |
| Age, Continuous | 34.8 years STANDARD_DEVIATION 9.6 | 31.7 years STANDARD_DEVIATION 9.4 | 28.5 years STANDARD_DEVIATION 7.3 | 30.5 years STANDARD_DEVIATION 8.6 |
| Annual Household Income $75,000 or more | 2 Participants | 1 Participants | 9 Participants | 12 Participants |
| Annual Household Income Less than $10,000 | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Annual Household Income Less than $15,000 ($10,000 to less than $15,000) | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Annual Household Income Less than $20,000 ($15,000 to less than $20,000) | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Annual Household Income Less than $25,000 ($20,000 to less than $25,000) | 2 Participants | 3 Participants | 6 Participants | 11 Participants |
| Annual Household Income Less than $35,000 ($25,000 to less than $35,000) | 4 Participants | 3 Participants | 10 Participants | 17 Participants |
| Annual Household Income Less than $50,000 ($35,000 to less than $50,000) | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
| Annual Household Income Less than $75,000 ($50,000 to less than $75,000) | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Annual Household Income Not reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 12 Participants | 33 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 9 Participants | 6 Participants | 24 Participants | 39 Participants |
| Region of Enrollment United States | 14 participants | 13 participants | 35 participants | 62 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 23 Participants | 33 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 12 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 | 0 / 35 |
| other Total, other adverse events | 0 / 14 | 0 / 13 | 0 / 35 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 35 |
Outcome results
Primary
Brain Activation During Smoking-related and Neutral Cues
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,
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Expect-Yes | 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 |
| Experimental: Expect-Yes | 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 |
| Experimental: Expect-No | Brain Activation During Smoking-related and Neutral Cues | Ventromedial prefrontal cortex ROI (10-mm sphere centered at MNI x = -1, y = 46, z = -7) | -1.6 contrast of parameter estimate | Standard Error 3.8 |
| Experimental: Expect-No | 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) | -4.2 contrast of parameter estimate | Standard Error 2.8 |
Comparison: The null hypothesis was that there is no difference in the population means of the two groups.p-value: 0.13t-test, 2 sided
Comparison: The null hypothesis was that there is no difference in the population means of the two groups.p-value: 0.25t-test, 2 sided
Primary
Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues
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,
Time frame: Approximately Day 7 (Visit 2)
Population: Participants who provided usable facial expression data were included in analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Expect-Yes | Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues | Valence during smoking-related cues | -.27 units on a scale | Standard Error 0.09 |
| Experimental: Expect-Yes | Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues | Valence during neutral cues | -.27 units on a scale | Standard Error 0.1 |
| Experimental: Expect-No | Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues | Valence during smoking-related cues | -.24 units on a scale | Standard Error 0.09 |
| Experimental: Expect-No | Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues | Valence during neutral cues | -.25 units on a scale | Standard Error 0.09 |
| Behavioral Testing | Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues | Valence during smoking-related cues | -.23 units on a scale | Standard Error 0.08 |
| Behavioral Testing | Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues | Valence during neutral cues | -.18 units on a scale | Standard Error 0.08 |
Comparison: The null hypothesis was that there is no difference in the population means of the two groups.p-value: 0.8t-test, 2 sided
Comparison: The null hypothesis was that there is no difference in the population means of the two groups.p-value: 0.87t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Expect-Yes | 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 |
| Experimental: Expect-Yes | 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 |
| Experimental: Expect-No | Brain Activation During Positive and Negative Emotion Cues | Ventromedial prefrontal cortex ROI (10-mm sphere centered at MNI x = -1, y = 46, z = -7) | 5.5 contrast of parameter estimate | Standard Error 2.8 |
| Experimental: Expect-No | 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) | -2.2 contrast of parameter estimate | Standard Error 5.2 |
Secondary
Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues
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,
Time frame: Approximately Day 7 (Visit 2)
Population: Participants who provided usable facial expression data were included in analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Expect-Yes | Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues | Valence during positive emotion cues | -.19 units on a scale | Standard Error 0.1 |
| Experimental: Expect-Yes | Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues | Valence during negative emotion cues | -.24 units on a scale | Standard Error 0.1 |
| Experimental: Expect-No | Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues | Valence during positive emotion cues | -.17 units on a scale | Standard Error 0.1 |
| Experimental: Expect-No | Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues | Valence during negative emotion cues | -.25 units on a scale | Standard Error 0.09 |
| Behavioral Testing | Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues | Valence during positive emotion cues | .03 units on a scale | Standard Error 0.05 |
| Behavioral Testing | Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues | Valence during negative emotion cues | -.12 units on a scale | Standard Error 0.04 |
Secondary
Nicotine Dependence
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Expect-Yes | Nicotine Dependence | 3.8 units on a scale | Standard Error 0.6 |
| Experimental: Expect-No | Nicotine Dependence | 4.1 units on a scale | Standard Error 0.6 |
| Behavioral Testing | Nicotine Dependence | 4.4 units on a scale | Standard Error 0.3 |
Secondary
Self-reported Affect During Positive and Negative Emotion Cues
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.
Time frame: Approximately Day 7 (Visit 2)
Population: Participants who provided usable ratings data were included in analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Expect-Yes | Self-reported Affect During Positive and Negative Emotion Cues | Self-reported affect during positive emotion cues | 7.6 units on a scale | Standard Error 0.2 |
| Experimental: Expect-Yes | Self-reported Affect During Positive and Negative Emotion Cues | Self-reported affect during negative emotion cues | 2.8 units on a scale | Standard Error 0.3 |
| Experimental: Expect-No | Self-reported Affect During Positive and Negative Emotion Cues | Self-reported affect during positive emotion cues | 6.7 units on a scale | Standard Error 0.3 |
| Experimental: Expect-No | Self-reported Affect During Positive and Negative Emotion Cues | Self-reported affect during negative emotion cues | 2.9 units on a scale | Standard Error 0.3 |
| Behavioral Testing | Self-reported Affect During Positive and Negative Emotion Cues | Self-reported affect during positive emotion cues | 6.4 units on a scale | Standard Error 0.3 |
| Behavioral Testing | Self-reported Affect During Positive and Negative Emotion Cues | Self-reported affect during negative emotion cues | 3.7 units on a scale | Standard Error 0.3 |
Secondary
Self-reported Affect During Smoking-related and Neutral Cues
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.
Time frame: Approximately Day 7 (Visit 2)
Population: Participants who provided usable ratings data were included in analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Expect-Yes | 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 |
| Experimental: Expect-Yes | 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 |
| Experimental: Expect-No | Self-reported Affect During Smoking-related and Neutral Cues | Self-reported affect during smoking-related cues | 5.5 units on a scale | Standard Error 0.3 |
| Experimental: Expect-No | Self-reported Affect During Smoking-related and Neutral Cues | Self-reported affect during neutral cues | 5.4 units on a scale | Standard Error 0.3 |
| Behavioral Testing | Self-reported Affect During Smoking-related and Neutral Cues | Self-reported affect during smoking-related cues | 5.1 units on a scale | Standard Error 0.7 |
| Behavioral Testing | Self-reported Affect During Smoking-related and Neutral Cues | Self-reported affect during neutral cues | 5.9 units on a scale | Standard Error 0.3 |
Secondary
Self-reported Urge to Smoke During Positive and Negative Emotion Cues
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Expect-Yes | 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 0.3 |
| Experimental: Expect-Yes | 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 0.5 |
| Experimental: Expect-No | Self-reported Urge to Smoke During Positive and Negative Emotion Cues | Self-reported urge during positive emotion cues | 4.0 units on a scale | Standard Error 0.6 |
| Experimental: Expect-No | Self-reported Urge to Smoke During Positive and Negative Emotion Cues | Self-reported urge during negative emotion cues | 5.8 units on a scale | Standard Error 0.4 |
Secondary
Self-reported Urge to Smoke During Smoking-related and Neutral Cues
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.
Time frame: Approximately Day 7 (Visit 2)
Population: Participants who provided usable ratings data were included in analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Expect-Yes | 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 |
| Experimental: Expect-Yes | 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 |
| Experimental: Expect-No | Self-reported Urge to Smoke During Smoking-related and Neutral Cues | Self-reported urge during smoking-related cues | 7.1 units on a scale | Standard Error 0.6 |
| Experimental: Expect-No | Self-reported Urge to Smoke During Smoking-related and Neutral Cues | Self-reported urge during neutral cues | 5.0 units on a scale | Standard Error 0.6 |
| Behavioral Testing | Self-reported Urge to Smoke During Smoking-related and Neutral Cues | Self-reported urge during smoking-related cues | 6.3 units on a scale | Standard Error 0.7 |
| Behavioral Testing | Self-reported Urge to Smoke During Smoking-related and Neutral Cues | Self-reported urge during neutral cues | 3.7 units on a scale | Standard Error 0.9 |