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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA052729 | 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 purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) cigarettes on experiences with craving, withdrawal, and pain among individuals with chronic back pain who smoke cigarettes daily.
The goal of this study is to evaluate the effects of very low nicotine content (VLNC) cigarettes on the dynamic associations between smoking, pain, and withdrawal among daily smokers with chronic (> 3 months) non-cancer back pain (n=48). Participants will complete an initial screening session to determine eligibility, followed by a baseline abstinence session in which measures of pain and withdrawal will be assessed following 24 hrs abstinence from smoking. At the conclusion of this session participants will receive training in ecological momentary assessment (EMA) procedures and software will be installed on their smartphone. Participants will then complete a 1-week baseline period, in which they will complete EMA while continuing to smoke usual brand cigarettes. During EMA, participants will receive 6 randomly spaced daily prompts, with 15 questions to complete about smoking behavior, mood, and current pain. In addition, participants will be asked to use their smartphone to indicate whenever they are about to smoke a cigarette. Three of these cigarettes each day will be randomly selected for assessment: in these cases participants will be asked to respond to the same 15 question before and after smoking the cigarette. Participants will also complete end of day questionnaires.
After the 1 week baseline period, participants will be randomly assigned to four weeks of either VLNCs (n=24) or normal nicotine content (NNC) cigarettes (n=24). During this period, participants will be asked to smoke only study cigarettes. Participants will attend weekly laboratory visits to provide biochemical verification of cigarette adherence (urine samples) and complete questionnaires. Study cigarettes will also be provided and collected at these visits. Two of the four weekly urine samples will be selected for analysis. Participants will also complete EMA during weeks 1 and 4 of study cigarette use. End of day questionnaires will continue throughout the 4 weeks.
At the conclusion of the study, participants will attend a final laboratory visit after abstaining from smoking for 24 hours. During this session, self-report measures of pain, craving, and withdrawal will be assessed, along with biochemical verification (breath sample) of abstinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLNC Group | Experimental | Participants in this condition will be provided with Spectrum NRC102/103 (nonmenthol/menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco with reported nicotine yield (ISO) of 0.03 +/- 0.01 mg and a tar yield of 9 +/- 1.5. Participants will be asked to smoke only study cigarettes for 4 weeks. |
|
| NNC Group | Active Comparator | Participants in this condition will be provided with Spectrum NRC600/601 (non-menthol/menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco with reported nicotine yield (ISO) of 0.8 +/- 0.15 mg and a tar yield of 10.5 +/- 1.5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECTRUM NRC 102/103 investigational cigarettes | Other | Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes Smoked Per Day | Average number of cigarettes smoked per day over the past week, as reported on timeline follow-back interview at each weekly visit | Weekly for 5 weeks |
| Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | The FTCD is a widely used 6-item measure of dependence, with total scores ranging from 0 (low dependence) to 10 (high dependence) | Weekly for 5 weeks |
| Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | The MNWS is a 7-item measure of withdrawal symptoms, with responses indicated on a likert scale ranging from 0 (none) to 4 (severe). The total score ranges from 0 to 28, with higher scores indicating greater withdrawal symptoms. | Weekly for 5 visits |
| Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | The BPI is a well-validated 11-item self-report measure. Pain intensity is calculated as the average of 3 items (worst pain, least pain, and average pain). Scores are averaged with the total score ranging from 0 to 10 with higher scores indicating more pain. | Weekly for 5 visits |
| Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS) | The MNWS is a 7-item measure of withdrawal symptoms, with responses indicated on a likert scale ranging from 0 (none) to 4 (severe). The total score ranges from 0 to 28, with higher scores indicating greater withdrawal symptoms. | Baseline (pre-intervention) abstinence session (i.e., prior to week 1), follow-up abstinence session (immediately after final week of cigarette use; i.e., week 5) |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI) | The PSI is a 9-item measure of pain as a motivator to smoke, smoking to cope with pain, and pain as a barrier to smoking cessation, with responses indicated on a 7-point likert scale ranging from 0 (not true at all) to 6 (extremely true). Scores are averaged and the total score ranges from 0-6, with higher scores indicating that pain is a greater motivator to smoke. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maggie Sweitzer | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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A total of 40 participants were determined to be eligible and enrolled in the study. Of these, 5 withdrew prior to randomization due to scheduling difficulty (n=2), PI decision following repeated no-shows (n=1), inability to abstain from smoking for the baseline abstinent visit (n=1) and loss to contact (n=1).
Participants were recruited from Duke University Medical Center and the surrounding area from August, 2023 through May, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | VLNC Group | Participants in this condition will be provided with Spectrum NRC102/103 (nonmenthol/menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco with reported nicotine yield (ISO) of 0.03 +/- 0.01 mg and a tar yield of 9 +/- 1.5. Participants will be asked to smoke only study cigarettes for 4 weeks. SPECTRUM NRC 102/103 investigational cigarettes: Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes |
| FG001 | NNC Group | Participants in this condition will be provided with Spectrum NRC600/601 (non-menthol/menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco with reported nicotine yield (ISO) of 0.8 +/- 0.15 mg and a tar yield of 10.5 +/- 1.5. SPECTRUM NRC 600/601 investigational cigarettes: Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | VLNC Group | Participants in this condition will be provided with Spectrum NRC102/103 (nonmenthol/menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco with reported nicotine yield (ISO) of 0.03 +/- 0.01 mg and a tar yield of 9 +/- 1.5. Participants will be asked to smoke only study cigarettes for 4 weeks. SPECTRUM NRC 102/103 investigational cigarettes: Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cigarettes Smoked Per Day | Average number of cigarettes smoked per day over the past week, as reported on timeline follow-back interview at each weekly visit | Posted | Mean | Standard Deviation | cigarettes/day | Weekly for 5 weeks |
|
5 weeks including 1 week pre-randomization (abstinence 1 to weekly visit 1) and 4 weeks of study cigarette use (weekly visit 1 abstinence 2)
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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 | VLNC Group | Participants in this condition will be provided with Spectrum NRC102/103 (nonmenthol/menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco with reported nicotine yield (ISO) of 0.03 +/- 0.01 mg and a tar yield of 9 +/- 1.5. Participants will be asked to smoke only study cigarettes for 4 weeks. SPECTRUM NRC 102/103 investigational cigarettes: Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dental extraction | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maggie Sweitzer | Duke University Medical Center | 919-668-0094 | maggie.sweitzer@duke.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 | Oct 21, 2024 | Jun 16, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2023 | Jun 25, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| SPECTRUM NRC 600/601 investigational cigarettes | Other | Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes |
|
| Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI) | The BPI is a well-validated 11-item self-report measure. Pain intensity is calculated as the average of 3 items (worst pain, least pain, and average pain). Scores are averaged with the total score ranging from 0 to 10 with higher scores indicating more pain. | Baseline (pre-intervention) abstinence session (i.e., before week 1), follow-up abstinence session (immediately after final week of cigarette use; i.e., week 5) |
| Weekly visits 1, 3, and 5 |
| Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder | The contemplation ladder is a single-item measure of a person's current thoughts about quitting smoking, ranging from 0 (I have no thought of quitting) to 10 (I am doing something to try to quit) | Weekly visits 1, 3, and 5 |
| Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) | The SEQ-12 is a 12-item measure yielding scores for self-efficacy when faced with both external (situational) or internal (e.g., affective) stimuli. Responses on each item range from 1 to 5, with higher scores indicating greater confidence in abstaining from smoking. Total score ranges from 12 to 60. | Weekly visits 1, 3, and 5 |
| Pain Intensity Ratings During Ecological Momentary Assessment | Responses to the question "Right now, how intense is your pain?", rated on a 1 (not at all) to 9 (extremely) likert scale at multiple timepoints throughout the day over the course of a week. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating more pain. | Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) |
| Smoking Urge Ratings During Ecological Momentary Assessment | Responses to question "How strong is your current urge to smoke?", rated on a 1 (not strong at all) to 9 (extremely strong) likert scale, assessed at multiple timepoints each day. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating greater smoking urge. | Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) |
| Negative Affect Ratings During Ecological Momentary Assessment | Average of responses to 4 negative affect items (anxious, irritable, guilty sad) using the question prompt, "Right now, how much are you feeling...?", rated on a 1 (not at all) to 9 (extremely) likert scale, assessed at multiple times per day. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating greater negative affect. | Baseline (pre-randomization; i.e., week 1), and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) |
| Intent to Smoke During Ecological Momentary Assessment | Proportion of "yes" responses to question "Are you about to smoke a cigarette right now?", assessed multiple times during the day. Total "yes" responses were divided by total observations within each week to calculate proportion of responses. | Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) |
| BG001 | NNC Group | Participants in this condition will be provided with Spectrum NRC600/601 (non-menthol/menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco with reported nicotine yield (ISO) of 0.8 +/- 0.15 mg and a tar yield of 10.5 +/- 1.5. SPECTRUM NRC 600/601 investigational cigarettes: Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes |
| BG002 | Total | Total of all reporting groups |
| 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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Participants in this condition will be provided with Spectrum NRC600/601 (non-menthol/menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco with reported nicotine yield (ISO) of 0.8 +/- 0.15 mg and a tar yield of 10.5 +/- 1.5.
SPECTRUM NRC 600/601 investigational cigarettes: Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes
|
|
|
| Primary | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | The FTCD is a widely used 6-item measure of dependence, with total scores ranging from 0 (low dependence) to 10 (high dependence) | Posted | Mean | Standard Deviation | score on a scale | Weekly for 5 weeks |
|
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|
| Primary | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | The MNWS is a 7-item measure of withdrawal symptoms, with responses indicated on a likert scale ranging from 0 (none) to 4 (severe). The total score ranges from 0 to 28, with higher scores indicating greater withdrawal symptoms. | Posted | Mean | Standard Deviation | score on a scale | Weekly for 5 visits |
|
|
|
|
| Primary | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | The BPI is a well-validated 11-item self-report measure. Pain intensity is calculated as the average of 3 items (worst pain, least pain, and average pain). Scores are averaged with the total score ranging from 0 to 10 with higher scores indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | Weekly for 5 visits |
|
|
|
|
| Primary | Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS) | The MNWS is a 7-item measure of withdrawal symptoms, with responses indicated on a likert scale ranging from 0 (none) to 4 (severe). The total score ranges from 0 to 28, with higher scores indicating greater withdrawal symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-intervention) abstinence session (i.e., prior to week 1), follow-up abstinence session (immediately after final week of cigarette use; i.e., week 5) |
|
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|
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| Primary | Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI) | The BPI is a well-validated 11-item self-report measure. Pain intensity is calculated as the average of 3 items (worst pain, least pain, and average pain). Scores are averaged with the total score ranging from 0 to 10 with higher scores indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-intervention) abstinence session (i.e., before week 1), follow-up abstinence session (immediately after final week of cigarette use; i.e., week 5) |
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| Other Pre-specified | Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI) | The PSI is a 9-item measure of pain as a motivator to smoke, smoking to cope with pain, and pain as a barrier to smoking cessation, with responses indicated on a 7-point likert scale ranging from 0 (not true at all) to 6 (extremely true). Scores are averaged and the total score ranges from 0-6, with higher scores indicating that pain is a greater motivator to smoke. | Posted | Mean | Standard Deviation | score on a scale | Weekly visits 1, 3, and 5 |
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| Other Pre-specified | Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder | The contemplation ladder is a single-item measure of a person's current thoughts about quitting smoking, ranging from 0 (I have no thought of quitting) to 10 (I am doing something to try to quit) | Posted | Mean | Standard Deviation | score on a scale | Weekly visits 1, 3, and 5 |
|
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|
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| Other Pre-specified | Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) | The SEQ-12 is a 12-item measure yielding scores for self-efficacy when faced with both external (situational) or internal (e.g., affective) stimuli. Responses on each item range from 1 to 5, with higher scores indicating greater confidence in abstaining from smoking. Total score ranges from 12 to 60. | Posted | Mean | Standard Deviation | score on a scale | Weekly visits 1, 3, and 5 |
|
|
|
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| Other Pre-specified | Pain Intensity Ratings During Ecological Momentary Assessment | Responses to the question "Right now, how intense is your pain?", rated on a 1 (not at all) to 9 (extremely) likert scale at multiple timepoints throughout the day over the course of a week. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating more pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) |
|
|
|
| Other Pre-specified | Smoking Urge Ratings During Ecological Momentary Assessment | Responses to question "How strong is your current urge to smoke?", rated on a 1 (not strong at all) to 9 (extremely strong) likert scale, assessed at multiple timepoints each day. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating greater smoking urge. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) |
|
|
|
| Other Pre-specified | Negative Affect Ratings During Ecological Momentary Assessment | Average of responses to 4 negative affect items (anxious, irritable, guilty sad) using the question prompt, "Right now, how much are you feeling...?", rated on a 1 (not at all) to 9 (extremely) likert scale, assessed at multiple times per day. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating greater negative affect. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-randomization; i.e., week 1), and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) |
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| Other Pre-specified | Intent to Smoke During Ecological Momentary Assessment | Proportion of "yes" responses to question "Are you about to smoke a cigarette right now?", assessed multiple times during the day. Total "yes" responses were divided by total observations within each week to calculate proportion of responses. | Posted | Mean | Standard Deviation | proportion of responses | Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) |
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| Post-Hoc | Changes in Abstinence-induced Craving as Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief) | The QSU-Brief is a 5-item measure of urge to smoke, with responses indicated on a 7-point likert scale ranging from 0 (strongly disagree) to 7 (strongly agree). Total scores range from 0 to 35, with higher scores indicating greater craving. | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-intervention) abstinence session (i.e., before week 1), follow-up abstinence session (immediately after final week of cigarette use; i.e., week 5) |
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| 0 |
| 19 |
| 0 |
| 19 |
| 12 |
| 19 |
| EG001 | NNC Group | Participants in this condition will be provided with Spectrum NRC600/601 (non-menthol/menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco with reported nicotine yield (ISO) of 0.8 +/- 0.15 mg and a tar yield of 10.5 +/- 1.5. SPECTRUM NRC 600/601 investigational cigarettes: Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes | 0 | 16 | 0 | 16 | 13 | 16 |
| depressive symptoms | Psychiatric disorders | Systematic Assessment |
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| nausea and dizziness | Gastrointestinal disorders | Systematic Assessment |
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| 100% increase in cigarettes/day | Product Issues | Systematic Assessment |
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| Elevated blood pressure | Vascular disorders | Systematic Assessment |
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| Fall, hurt ribs | Injury, poisoning and procedural complications | Systematic Assessment |
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| dizziness and blurred vision | Nervous system disorders | Systematic Assessment |
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| pinched nerve in hand | Nervous system disorders | Systematic Assessment |
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| heartburn | Gastrointestinal disorders | Systematic Assessment |
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| irregular heartrate | Cardiac disorders | Systematic Assessment |
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| tingling in chest | Nervous system disorders | Systematic Assessment |
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| knee, joint, or shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| mild pain in sternum | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| sinus irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| viral infection | Infections and infestations | Systematic Assessment |
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| increased stress | Social circumstances | Systematic Assessment |
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| increased anxiety | Psychiatric disorders | Systematic Assessment |
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| increased irritability | Psychiatric disorders | Systematic Assessment |
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| increased back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| thyroid flare-up | Endocrine disorders | Systematic Assessment |
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| abcess | Infections and infestations | Systematic Assessment |
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| blocked salivary duct | Gastrointestinal disorders | Systematic Assessment |
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| Grief/sadness | Social circumstances | Systematic Assessment |
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| narcolepsy diagnosis | Nervous system disorders | Systematic Assessment |
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| sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| minor back injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| cirrhosis diagnosis | Hepatobiliary disorders | Systematic Assessment |
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| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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