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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA045853 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Expect-Yes | Experimental | 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. |
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| Experimental: Expect-No | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verbal smoking expectancy manipulation | Behavioral | Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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, | Approximately Day 7 (Visit 2) |
| 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, | Approximately Day 7 (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennsylvania State University | University Park | Pennsylvania | 16870 | United States |
De-identified data and related materials (e.g., scripts) will be made publicly available on the Open Science Framework (OSF) to facilitate replication. Similarly, unthresholded fMRI statistical maps will be made publicly available on NeuroVault.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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, | 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. | Posted | Mean | Standard Error | contrast of parameter estimate | Approximately Day 7 (Visit 2) |
Adverse data were collected for the duration of each of the two study visits, which were held an average of approximately 12 days apart.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Wilson | The Pennsylvania State University | 8148656219 | sjw42@psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2024 | Nov 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| Approximately Day 7 (Visit 2) |
| 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. | Approximately Day 7 (Visit 2) |
| 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. | Day 1 (Visit 1) |
| 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. | Approximately Day 7 (Visit 2) |
| 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, | Approximately Day 7 (Visit 2) |
| 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. | Approximately Day 7 (Visit 2) |
| 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. | Approximately Day 7 (Visit 2) |
| BG001 |
| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Annual Household Income | Count of Participants | Participants |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
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| 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, | Participants who provided usable facial expression data were included in analyses. | Posted | Mean | Standard Error | units on a scale | Approximately Day 7 (Visit 2) |
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| 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. | Participants who provided usable ratings data were included in analyses. | Posted | Mean | Standard Error | units on a scale | Approximately Day 7 (Visit 2) |
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| 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. | Participants who provided usable ratings data were included in analyses. | Posted | Mean | Standard Error | units on a scale | Approximately Day 7 (Visit 2) |
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| 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. | Only participants with usable data for the specified outcome were included in the analysis (i.e., those with missing data were excluded). | Posted | Mean | Standard Error | units on a scale | Day 1 (Visit 1) |
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| 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. | 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. | Posted | Mean | Standard Error | contrast of parameter estimate | Approximately Day 7 (Visit 2) |
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| 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, | Participants who provided usable facial expression data were included in analyses. | Posted | Mean | Standard Error | units on a scale | Approximately Day 7 (Visit 2) |
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| 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. | 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. | Posted | Mean | Standard Error | units on a scale | Approximately Day 7 (Visit 2) |
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| 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. | Participants who provided usable ratings data were included in analyses. | Posted | Mean | Standard Error | units on a scale | Approximately Day 7 (Visit 2) |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
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The null hypothesis was that there is no difference in the population means of the two groups. |
| t-test, 2 sided |
| .87 |
Statistical significance was defined a priori as p<0.05. |
| Other |
Independent-samples t-tests were conducted to compare mean valence values during neutral cues between the Expect-Yes and Expect-No groups. |
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