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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA036105 | U.S. NIH Grant/Contract | View source | |
| FP00006477_SA007 | Other Grant/Funding Number | Subaward Number |
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COVID concerns, funding delays led to cancellation of project
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.
The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use a nicotine "salt" (protonated) aerosol, relative to an unprotonated aerosol or their own brand of cigarettes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
|
| ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
|
| ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subox Mini C with Avail 18 mg nicotine salt (protonated) | Other | Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine salt (protonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Nicotine | Change in plasma nicotine level | Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period. |
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Inclusion Criteria:
Participants must be:
Exclusion Criteria:
• Women if breast-feeding or test positive for pregnancy (by urinalysis) at screening
Some study details about eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Paul T Harrell, Ph.D. | Eastern Virginia Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Virginia Medical School | Norfolk | Virginia | 23510 | United States |
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This is a within-subjects design study with 3 conditions on 3 separate follow-ups after an initial screening visit. Enrolled participants were sometimes excluded from the study, primarily due to loss to follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Own Brand Cigarette First, Then ENDS With Protonated Nicotine, Then ENDS With Unprotonated Nicotine | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| FG001 | ENDS With Unprotonated Nicotine First, Then ENDS With Protonated Nicotine, Then Own Brand Cigarette | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| FG002 | ENDS With Protonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Unprotonated Nicotine | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| FG003 | ENDS With Protonated Nicotine First, Then ENDS With Unprotonated Nicotine, Then Own Brand Cigarette | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| FG004 | Own Brand Cigarette First, Then ENDS With Unprotonated Nicotine, Then ENDS With Protonated Nicotine | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| FG005 | ENDS With Unprotonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Protonated Nicotine | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study ended early due to COVID and funding delays.
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| ID | Title | Description |
|---|---|---|
| BG000 | Own Brand Cigarette First, Then ENDS With Protonated Nicotine, Then ENDS With Unprotonated Nicotine | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Plasma Nicotine | Change in plasma nicotine level | We were unable to collect this outcome measure (plasma nicotine) due to staffing issues and difficulties with blood draws. | Posted | Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period. |
|
6 months
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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 | Own Brand Cigarette | Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Own brand cigarette: Participants will be instructed to take one puff of a cigarette matching their typical brand every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Harrell | Eastern Virginia Medical School | 757-446-6047 | harrelpt@evms.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 | Feb 17, 2020 | Nov 28, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2020 | Nov 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
|
| Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
|
| ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine | Experimental | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. |
|
|
| Subox Mini C with Avail 18 mg nicotine (unprotonated) | Other | Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine (unprotonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. |
|
| Own brand cigarette | Other | Participants will be instructed to take one puff of a cigarette matching their typical brand every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. |
|
| BG001 | ENDS With Unprotonated Nicotine First, Then ENDS With Protonated Nicotine, Then Own Brand Cigarette | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| BG002 | ENDS With Protonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Unprotonated Nicotine | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| BG003 | ENDS With Protonated Nicotine First, Then ENDS With Unprotonated Nicotine, Then Own Brand Cigarette | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| BG004 | Own Brand Cigarette First, Then ENDS With Unprotonated Nicotine, Then ENDS With Protonated Nicotine | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| BG005 | ENDS With Unprotonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Protonated Nicotine | In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired |
| BG006 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| OG001 | ENDS: Subox Mini C With 18 mg Nicotine Salt (Protonated) | Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Subox Mini C with Avail 18 mg nicotine salt (protonated): Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine salt (protonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. |
| OG002 | ENDS: Subox Mini C With 18 mg Nicotine Regular (Unprotonated) | Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Subox Mini C with Avail 18 mg nicotine (unprotonated): Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine (unprotonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | ENDS: Subox Mini C With 18 mg Nicotine Salt (Protonated) | Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Subox Mini C with Avail 18 mg nicotine salt (protonated): Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine salt (protonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | ENDS: Subox Mini C With 18 mg Nicotine Regular (Unprotonated) | Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired. Subox Mini C with Avail 18 mg nicotine (unprotonated): Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine (unprotonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |