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The purpose of this study is to assess if access to an electronic nicotine delivery device, or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among individuals diagnosed with schizophrenia compared to nicotine patch alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Replacement Therapy - Nicotine Patch | Active Comparator | Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. |
|
| Nicotine Replacement Therapy + E-cigarette | Experimental | The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Smoking as Assessed by Breath Carbon Monoxide Levels | Baseline, Week 5 | |
| Change in Smoking as Assessed by Urinary Cotinine Levels | Baseline, Week 5 | |
| Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below. | Baseline |
| Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below. | week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Assessed by Percent of Participants Who Completed the Study | week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Ho Yoon, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston | Houston | Texas | 77054 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Replacement Therapy - Nicotine Patch | Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. |
| FG001 | Nicotine Replacement Therapy + E-cigarette | Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. E-cigarette: The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Replacement Therapy - Nicotine Patch | Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. |
| BG001 | Nicotine Replacement Therapy + E-cigarette |
| 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 | Change in Smoking as Assessed by Breath Carbon Monoxide Levels | Posted | Mean | Standard Deviation | parts per million (ppm) | Baseline, Week 5 |
|
5 weeks
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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 | Nicotine Replacement Therapy - Nicotine Patch | Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jin Ho Yoon, PhD | The University of Texas Health Science Center at Houston | (713) 486-2796 | Jin.Ho.Yoon@uth.tmc.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 | May 17, 2017 | Jun 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D000072137 | Vaping |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| E-cigarette | Drug | The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA). |
|
Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. E-cigarette: The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA). |
| 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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| Primary | Change in Smoking as Assessed by Urinary Cotinine Levels | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 5 |
|
|
|
| Primary | Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below. | Posted | Mean | Standard Deviation | number of cigarettes per day | Baseline |
|
|
|
| Secondary | Feasibility as Assessed by Percent of Participants Who Completed the Study | Posted | Number | percent of participants | week 5 |
|
|
|
| Primary | Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below. | Posted | Mean | Standard Deviation | number of cigarettes per day | week 5 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Nicotine Replacement Therapy + E-cigarette | Nicotine Patch: Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. E-cigarette: The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA). | 0 | 3 | 0 | 3 | 3 | 3 |
| Not sleeping well | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Nervousness | Psychiatric disorders | Systematic Assessment |
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| Blurry vision | Eye disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Tremor (shaky hands) | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Stomach pain (cramps) | General disorders | Systematic Assessment |
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| Muscle aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Heart racing | Cardiac disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Increased urination | Renal and urinary disorders | Systematic Assessment |
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| Change in sexual function | Reproductive system and breast disorders | Systematic Assessment |
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| Weakness | General disorders | Systematic Assessment |
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| Sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dry mouth | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Difficulty walking | General disorders | Systematic Assessment |
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| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Fever/chills | General disorders | Systematic Assessment |
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| Loss of appetite | General disorders | Systematic Assessment |
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| Confusion | General disorders | Systematic Assessment |
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| Cloudiness | General disorders | Systematic Assessment |
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| Memory loss | General disorders | Systematic Assessment |
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| D001523 |
| Mental Disorders |