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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA048428 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study aims to determine the health effects of very low nicotine content in cigarettes, in conjunction with the availability of nicotine-containing electronic cigarettes (e-cigs) among smokers with mental health conditions (SMHC).
The specific objective of this study is to recruit a cohort of 240 current exclusive daily SMHC (diagnosed using the MINI International Neuropsychiatric Interview) and to measure a comprehensive battery of behavioral and health indicators at 4, 8, 12 and 16 weeks after being randomized to use either normal nicotine content (NNC) Spectrum cigarettes (11.6 mg nicotine/cigarette) or very low nicotine content (VLNC) Spectrum cigarettes (0.2 mg nicotine/cigarette) while also having access to an electronic cigarette (containing either 0 nicotine or high nicotine e-liquid) in a randomized double-blind, placebo-controlled, 2 by 2 design. All participants will be followed up with a study visit 4 weeks after the final randomized visit to identify whether they have continued to use e-cigs/cigarettes and to assess their motivation in smoking abstinence.
Our central hypothesis is that key markers of harms to health (e.g. urinary NNAL, exhaled carbon monoxide, measures of addiction, and mental distress) will be significantly improved among SMHC who are provided VLNC cigarettes and high nicotine e-cigs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC cigarettes + High Nicotine Containing E-cigarette | Experimental | Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid. |
|
| NNC cigarettes + Zero Nicotine Containing E-cigarette | Experimental | Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid. |
|
| VLNC cigarettes + High Nicotine Containing E-cigarette | Experimental | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid. |
|
| VLNC cigarettes + Zero Nicotine Containing E-cigarette | Experimental | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Nicotine Content research cigarettes | Other | Research cigarettes with 11.6 mg nicotine/cigarette. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) | Measure of tobacco-specific nitrosamine | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Carbon Monoxide | Measure of cigarette smoke exposure | Week 16 |
| Kessler-6 Score | Measure of serious psychological distress. This scale is a brief, self-report tool used to assess psychological distress. Scores range from 0-24, with higher scores indicating greater distress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Foulds, PhD | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
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88 participants consented and enrolled in the pre-randomization phase of the study. Eight participants were lost to follow-up or withdrawn from the study before being randomized to a study intervention. Therefore, 80 participants were randomized to a study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | NNC Cigarettes + High Nicotine Containing E-cigarette | Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid. Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette. High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid |
| FG001 | NNC Cigarettes + Zero Nicotine Containing E-cigarette | Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid. Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette. Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid |
| FG002 | VLNC Cigarettes + High Nicotine Containing E-cigarette | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid. High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette. |
| FG003 | VLNC Cigarettes + Zero Nicotine Containing E-cigarette | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette. Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization Period |
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| Week 20 Follow up |
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| ID | Title | Description |
|---|---|---|
| BG000 | NNC Cigarettes + High Nicotine Containing E-cigarette | Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid. Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette. High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid |
| 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 | Urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) | Measure of tobacco-specific nitrosamine | The Overall Number of Participants Analyzed includes participants with non-missing values at Week 16. Therefore, in one of the groups, 20 people were randomized and 13 people completed the randomization phase, but only 12 of the samples could be analyzed. | Posted | Mean | Standard Deviation | pg/mg creatinine | Week 16 |
|
20 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
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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 | NNC Cigarettes + High Nicotine Containing E-cigarette | Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid. Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette. High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolle Krebs | Penn State College of Medicine | 7175315673 | nkrebs@pennstatehealth.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 | Jan 23, 2025 | Jul 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2024 | Jul 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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2 X 2 factorial design
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| High Nicotine e-cigarette | Other | E-cigarette containing high nicotine e-liquid |
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| Very Low Nicotine Content research cigarettes | Other | Research cigarettes with 0.2 mg nicotine/cigarette. |
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| Zero Nicotine e-cigarette | Other | E-cigarette containing zero nicotine e-liquid |
|
| Week 16 |
| Penn State Cigarette Dependence Index | Measure of cigarette dependence. This 10-item scale (with scores ranging from 0 to 20) was developed to measure cigarette dependence, where a score of 0 indicates no cigarette dependence and 20 indicates maximum cigarette dependence. | Week 16 |
| Penn State Electronic Cigarette Dependence Index | Measure of e-cigarette dependence. This 10-item scale (with scores ranging from 0 to 20) was developed to measure e-cigarette dependence, where a score of 0 indicates no cigarette dependence and 20 indicates maximum e-cigarette dependence. | Week 16 |
| Cigarette Abstinence | No cigarette use in the past 7 days and exhaled carbon monoxide < 6ppm | Week 20 |
| Withdrawal by Subject |
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| PI decision |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | NNC Cigarettes + Zero Nicotine Containing E-cigarette | Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid. Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette. Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid |
| BG002 | VLNC Cigarettes + High Nicotine Containing E-cigarette | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid. High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette. |
| BG003 | VLNC Cigarettes + Zero Nicotine Containing E-cigarette | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette. Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | 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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| Cigarettes per day | Mean | Standard Deviation | cigarettes per day |
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| OG001 |
| NNC Cigarettes + Zero Nicotine Containing E-cigarette |
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid. Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette. Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid |
| OG002 | VLNC Cigarettes + High Nicotine Containing E-cigarette | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid. High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette. |
| OG003 | VLNC Cigarettes + Zero Nicotine Containing E-cigarette | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette. Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid |
|
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| Secondary | Exhaled Carbon Monoxide | Measure of cigarette smoke exposure | The Overall Number of Participants Analyzed includes participants with non-missing values at Week 16. In two of the groups, 1 person had missing CO values. | Posted | Mean | Standard Deviation | parts per million | Week 16 |
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|
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| Secondary | Kessler-6 Score | Measure of serious psychological distress. This scale is a brief, self-report tool used to assess psychological distress. Scores range from 0-24, with higher scores indicating greater distress | The Overall Number of Participants Analyzed includes all participants with non-missing values at Week 16. In the VLNC cigarettes + High Nicotine Containing E-cigarette group, two participants did not complete the entire Week 16 visit, but they did complete the Kessler-6 survey for Week 16. Therefore, their Kessler-6 survey data are included in this analysis even though they were not included in the final sample size for Week 16, resulting in a sample size of n=15 for this group. | Posted | Mean | Standard Deviation | score on a scale | Week 16 |
|
|
|
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| Secondary | Penn State Cigarette Dependence Index | Measure of cigarette dependence. This 10-item scale (with scores ranging from 0 to 20) was developed to measure cigarette dependence, where a score of 0 indicates no cigarette dependence and 20 indicates maximum cigarette dependence. | The Overall Number of Participants Analyzed includes everyone with non-missing values at Week 16. In the VLNC cig+High Nic E-cig group, 1 person did not complete the entire Week 16 visit, but they did complete the Cig Dep survey for Week 16. Therefore, their Cig Dep survey data are included in this analysis, even though they were not included in the final sample size for Week 16, resulting in a sample size of n=14 for this group. 1 person had missing data in the VLNC cig+Zero Nic E-cig. | Posted | Mean | Standard Deviation | score on a scale | Week 16 |
|
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|
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| Secondary | Penn State Electronic Cigarette Dependence Index | Measure of e-cigarette dependence. This 10-item scale (with scores ranging from 0 to 20) was developed to measure e-cigarette dependence, where a score of 0 indicates no cigarette dependence and 20 indicates maximum e-cigarette dependence. | The Overall Number of Participants Analyzed includes everyone with non-missing values at Week 16. In the VLNC cig+High Nic E-cig group, 1 person did not complete the entire Week 16 visit, but they did complete the E-cig Dep survey for Week 16. Therefore, their E-cig Dep survey data are included in this analysis, even though they were not included in the final sample size for Week 16, resulting in a sample size of n=14 for this group. 2 people had missing data in the VLNC cig+0 Nic E-cig group. | Posted | Mean | Standard Deviation | score on a scale | Week 16 |
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| Secondary | Cigarette Abstinence | No cigarette use in the past 7 days and exhaled carbon monoxide < 6ppm | This is an intent-to-treat analysis so everyone who was randomized was included in the sample analyzed, regardless of whether they completed the Week 20 assessment. Those who did not complete the Week 20 assessment were assumed to be non-abstainers. This is normal practice in smoking cessation research. | Posted | Count of Participants | Participants | Week 20 |
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|
|
| 0 |
| 20 |
| 4 |
| 20 |
| 7 |
| 20 |
| EG001 | NNC Cigarettes + Zero Nicotine Containing E-cigarette | Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid. Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette. Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid | 0 | 20 | 4 | 20 | 11 | 20 |
| EG002 | VLNC Cigarettes + High Nicotine Containing E-cigarette | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid. High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette. | 0 | 20 | 2 | 20 | 6 | 20 |
| EG003 | VLNC Cigarettes + Zero Nicotine Containing E-cigarette | Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette. Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid | 0 | 20 | 1 | 20 | 8 | 20 |
| Pregnancy loss | Pregnancy, puerperium and perinatal conditions | CTCAE v5.0 | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Self-injurious ideation | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Surgical and Medical Procedures, other back electrodes | Surgical and medical procedures | CTCAE v5.0 | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Infections and infestations - Other, influenza | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
|
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