Trial Outcomes & Findings for Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study (NCT NCT04231539)

NCT ID: NCT04231539

Last Updated: 2025-10-31

Results Overview

The maximum nicotine concentration in blood plasma

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4.

Results posted on

2025-10-31

Participant Flow

Participant milestones

Participant milestones
Measure
Product Sequence D
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence A then B then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco
Product sequence B then C then A then D
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product sequence D then B then A then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product sequence C then D then B then A
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product sequence A then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco
Product sequence D then C then B then A
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product sequence A then D then B then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product sequence D then A then C then B
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product sequence C then D then A then B
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product sequence A then C then D then B
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence A then B then D then C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product sequence B then A then D thn C
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product sequence B then D then C then A
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Overall Study
STARTED
2
1
1
1
1
1
1
1
1
1
1
1
1
1
Overall Study
COMPLETED
0
0
1
1
1
0
1
1
1
1
1
1
1
1
Overall Study
NOT COMPLETED
2
1
0
0
0
1
0
0
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Product Sequence D
n=2 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence A Then B Then C
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco
Product Sequence B Then C Then A Then D
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence D Then B Then A Then C
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence C Then D Then B Then A
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence A Then C
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco
Product Sequence D Then C Then B Then A
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence A Then D Then B Then C
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence D Then A Then C Then B
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence C Then D Then A Then B
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence A Then C Then D Then B
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence A Then B Then D Then C
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence B Then A Then D Thn C
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Product Sequence B Then D Then C Then A
n=1 Participants
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco
Total
n=15 Participants
Total of all reporting groups
Age, Continuous
26 years
STANDARD_DEVIATION 2.8 • n=5 Participants
24 years
STANDARD_DEVIATION na • n=7 Participants
55 years
STANDARD_DEVIATION na • n=5 Participants
37 years
STANDARD_DEVIATION na • n=4 Participants
21 years
STANDARD_DEVIATION na • n=21 Participants
21 years
STANDARD_DEVIATION na • n=8 Participants
24 years
STANDARD_DEVIATION na • n=8 Participants
23 years
STANDARD_DEVIATION na • n=24 Participants
29 years
STANDARD_DEVIATION na • n=42 Participants
26 years
STANDARD_DEVIATION na • n=42 Participants
22 years
STANDARD_DEVIATION na • n=42 Participants
32 years
STANDARD_DEVIATION na • n=42 Participants
33 years
STANDARD_DEVIATION na • n=36 Participants
32 years
STANDARD_DEVIATION na • n=36 Participants
28.7 years
STANDARD_DEVIATION 8.7 • n=24 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=36 Participants
0 Participants
n=36 Participants
5 Participants
n=24 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
1 Participants
n=24 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=36 Participants
1 Participants
n=36 Participants
10 Participants
n=24 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
2 Participants
n=24 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
1 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
1 Participants
n=36 Participants
1 Participants
n=36 Participants
12 Participants
n=24 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
1 Participants
n=24 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants

PRIMARY outcome

Timeframe: Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4.

Population: All treated and eligible patients

The maximum nicotine concentration in blood plasma

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=13 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Maximum Concentration of Nicotine in Plasma (Cmax)
5.7 ng/mL
Standard Error 0.8
11.8 ng/mL
Standard Error 3.3
6.7 ng/mL
Standard Error 1.3
8.1 ng/mL
Standard Error 1.7

PRIMARY outcome

Timeframe: Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4.

Population: All treated and eligible patients

Area under the plasma nicotine concentration over time curve

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=13 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Area Under the Concentration-time Curve (AUC)
128.8 ng*min/mL
Standard Error 40.8
295.6 ng*min/mL
Standard Error 126.7
177.3 ng*min/mL
Standard Error 51.7
199.7 ng*min/mL
Standard Error 71.7

PRIMARY outcome

Timeframe: Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4.

Population: All treated and eligible patients

Time to maximum nicotine concentration in the blood plasma

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=13 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Time to Maximum Concentration
11.5 minutes
Standard Error 1.6
9.8 minutes
Standard Error 1.5
11.7 minutes
Standard Error 1.5
8.6 minutes
Standard Error 1.3

SECONDARY outcome

Timeframe: 1 minute post puffing for 4 weeks

Population: All treated and eligible patients

Subjective Measure of Perceived Harshness (Likert, 1-5: 1 = best outcome, 5 = worst outcome).

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=13 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Perceived Harshness of Experimental Product Sampled
4.85 score on a scale
Standard Error 0.1
2.92 score on a scale
Standard Error 0.4
4.62 score on a scale
Standard Error 0.1
3.08 score on a scale
Standard Error 0.4

SECONDARY outcome

Timeframe: 120 minutes after session start on last session (session 4)

Population: All treated and eligible patients

Nicotine Solution Rating Scale that orders each of the four products from 1 to 4, with 1 being least satisfying and 4 being most satisfying. Mean rank is provided with a possible score of 1 through 4.

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=13 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Perceived Satisfaction of Experimental Product Sampled
3.08 score on a scale
Standard Error 0.3
3.75 score on a scale
Standard Error 0.4
3.77 score on a scale
Standard Error 0.4
4.23 score on a scale
Standard Error 0.3

SECONDARY outcome

Timeframe: 1 minute post puffing for 4 weeks

Population: All treated and eligible patients

Drug Effects Questionnaire Item #1 - perceived liking of the experimental product assessed by the question, "Do you like any of the effects you are feeling right now?" on a Likert scale from 0 (not at all) to 100 (extremely), with lower scores representing less liking of the experimental product. Mean is provided with possible scores between 0 and 100.

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=13 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Perceived Liking of Experimental Product Sampled
45.9 score on a scale
Standard Error 5.2
55.2 score on a scale
Standard Error 4.0
46.5 score on a scale
Standard Error 6.0
52.5 score on a scale
Standard Error 5.4

SECONDARY outcome

Timeframe: 5 minutes pre puffing and 3 minutes post puffing for 4 weeks

Population: All treated and eligible patients

Minnesota Nicotine Withdrawal Scale Change Minnesota Nicotine Withdrawal scale measures 8 facets of withdrawal and results in a total score. We use change from 5 minutes Pre-puffing to 3 minutes post puffing session. Individual questions are scored 0 (none/better) to 4 (severe/worse). And then the scores are totaled. Positive change score = more withdrawal symptoms. Change score can range from -32 to 36). Positive change score = worse withdrawal symptoms Individual questions are scored 0 (none/better) to 4 (severe/worse). And then the scores are totaled.

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=13 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Minnesota Nicotine Withdrawal Scale Change (Change From Pre- to Post-)
0.5 score on a scale
Standard Error 0.7
0.7 score on a scale
Standard Error 0.7
1.5 score on a scale
Standard Error 0.5
-0.5 score on a scale
Standard Error 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 minutes post puffing for 4 weeks

Population: All treated and eligible patients

Demand intensity is a behavioral economic estimated measure of consumption at zero cost in a experimental marketplace focused on purchasing of tobacco and nicotine products over increasing price of one product while others stay the same price. Participants were asked to purchase tobacco products (12 options) for one week's use. At each of the four sessions, participants experienced a marketplace with e-cigarette liquid prices of $1.63, $3.25, $6.50, and $13.00, while the prices of the other 11 tobacco products remained the same. Units purchased are transformed into mg of nicotine and nonlinear regression is used to estimate the purchasing when e-cigarettes are free/demand intensity, which is reported here. Higher scores indicate more mg of nicotine from e-cigarettes were purchased

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=10 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=10 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=10 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=10 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Intensity of Demand or Estimated Milligrams E-cigarettes Purchased at Free Cost for Each Device Sampled
908.3 mg of nicotine
Interval 425.1 to 2022.0
1142 mg of nicotine
Interval 539.2 to 2926.0
785.5 mg of nicotine
Interval 416.1 to 1521.0
985.8 mg of nicotine
Interval 475.7 to 2416.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 minutes post puffing for 4 weeks

Population: All treated and eligible patients

Demand elasticity , or sensitivity to price, is a behavioral economic measure of of the rate of purchasing decline over increasing cost for e-cigarettes. At each of the four sessions, participants experienced a marketplace with e-cigarette liquid prices of $1.63, $3.25, $6.50, and $13.00, while the prices of the other 11 tobacco products remained the same. Units purchased are transformed into mg of nicotine and nonlinear regression is used to estimate the purchasing when e-cigarettes are free/demand intensity, which is reported here. Higher scores indicate more sensitivity to price, also called inelastic demand.

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=12 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=13 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Elasticity of Demand or Sensitivity to Price for Each Device Sampled
0.0005 mg nicotine per dollar
Interval 0.0002 to 0.0007
0.0004 mg nicotine per dollar
Interval 0.0002 to 0.0006
0.0004 mg nicotine per dollar
Interval 0.0002 to 0.0006
0.0005 mg nicotine per dollar
Interval 0.0003 to 0.0007

OTHER_PRE_SPECIFIED outcome

Timeframe: 120 minutes post puffing for 4 weeks

Population: All treated and eligible patients

Substitution is the slope of the line regressing consumption of the substitute product onto the price of cigarettes (cross-price elasticity). A positive coefficient indicates substitution (use of the substitute increases with increasing cigarette price). A negative value indicates complementarity (use of the substitute declines with increasing cigarette price). A value of 0 indicates no relationship.

Outcome measures

Outcome measures
Measure
A: Unflavored Free-based Nicotine Form
n=10 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored.
B: Unflavored Salt-based Nicotine Form
n=10 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored.
C: Tobacco Flavor Free-based Nicotine Form
n=10 Participants
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
D: Tobacco Flavor Salt-based Nicotine Form
n=10 Participants
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
Substitution Levels of Alternative Tobacco Products
JUUL Virginia Tobacco
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
7.377 mg nicotine per dollar
Interval -0.5177 to 15.27
Substitution Levels of Alternative Tobacco Products
Revel Dark Mint
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
Substitution Levels of Alternative Tobacco Products
Marlboro Menthols
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
Substitution Levels of Alternative Tobacco Products
Camel Snus Mellow
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
Substitution Levels of Alternative Tobacco Products
IQOS Menthol
4.86 mg nicotine per dollar
Interval 0.398 to 9.359
4.389 mg nicotine per dollar
Interval 1.23 to 7.548
4.432 mg nicotine per dollar
Interval -0.622 to 9.485
2.43 mg nicotine per dollar
Interval -0.9026 to 5.762
Substitution Levels of Alternative Tobacco Products
IQOS Tobacco
0 mg nicotine per dollar
Interval 0.0 to 0.0
0.2552 mg nicotine per dollar
Interval -2.385 to 2.895
2.382 mg nicotine per dollar
Interval -0.1672 to 4.931
1.813 mg nicotine per dollar
Interval -2637.0 to 6.262
Substitution Levels of Alternative Tobacco Products
JUUL Classic Tobacco
-0.000000000000 mg nicotine per dollar
Interval -87.64 to 87.64
8.167 mg nicotine per dollar
Interval -69.45 to 85.78
2.554 mg nicotine per dollar
Interval -81.9 to 87.01
-4.175 mg nicotine per dollar
Interval -95.61 to 87.26
Substitution Levels of Alternative Tobacco Products
JUUL Menthol
15.54 mg nicotine per dollar
Interval -38.02 to 69.11
17.31 mg nicotine per dollar
Interval -36.31 to 70.93
14.75 mg nicotine per dollar
Interval -32.1 to 61.61
18.28 mg nicotine per dollar
Interval -26.91 to 63.47
Substitution Levels of Alternative Tobacco Products
Revel Mint
4.232 mg nicotine per dollar
Interval -1.547 to 10.01
0.2371 mg nicotine per dollar
Interval -2.216 to 2.69
4.663 mg nicotine per dollar
Interval -0.6079 to 9.935
0.2371 mg nicotine per dollar
Interval -2.216 to 2.69
Substitution Levels of Alternative Tobacco Products
Marlboro Reds
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
Substitution Levels of Alternative Tobacco Products
Camel Snus Frost
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0
0 mg nicotine per dollar
Interval 0.0 to 0.0

Adverse Events

A: Unflavored Free-based Nicotine Form

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

B: Unflavored Salt-based Nicotine Form

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

C: Tobacco Flavor Free-based Nicotine Form

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

D: Tobacco Flavor Salt-based Nicotine Form

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Comprehensive Cancer Center

Phone: 716-845-2300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place