Assess the Influence of Nicotine Flux and Nicotine Form on Subjective Effects Related to Dependency

NCT05430334 | Completed Results

• 2 other identifiers: American University Of Beirut1R01DA052565-01A1
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Electronic nicotine delivery systems (ENDS) heat and vaporize a nicotine-containing liquid to produce an aerosol that can deliver nicotine to the blood and the brain. ENDS use has increased rapidly in the last decade, especially among youth: over 20% of US high school students are current ENDS users, and there is evidence of nicotine dependence in this population. Federal legislation has been proposed that would restrict ENDS liquid nicotine concentration to make ENDS "significantly less addictive and appealing to youth." However, these and other efforts to curb addiction by limiting nicotine liquid concentration are unlikely to succeed because nicotine emissions from ENDS depend on multiple variables. To achieve the intended public health aims, regulations targeting addiction must focus on nicotine delivery, not nicotine concentration. While nicotine delivery cannot be regulated directly, the rate at which an ENDS emits nicotine, the "nicotine flux", can be regulated and, importantly, predicted based on a few device design and operating variables. However, to date there is no empirical evidence demonstrating the relationship between flux and delivery, nor between flux and the subjective effects that support nicotine dependence. Closing this gap is essential for providing an effective framework for regulating ENDS. At the American University of Beirut, the investigators will assess the relationship between nicotine flux, form, and subjective effects. Participants will use ENDS devices with varying nicotine fluxes and forms. Dependency measures, such as urge to smoke, craving, and abstinence, will be assessed. The outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and exposure to toxicants. In summary, this project will provide the empirical evidence needed for public health agencies to use nicotine flux as an encompassing and convenient construct to regulate nicotine delivery from ENDS.

Conditions

Nicotine Vaping; Nicotine Dependence; Nicotine Addiction

Keywords

Nicotine; Nicotine Flux; Vaping; ENDS; Aerosol; Combustible

Outcome Measures

Primary Outcomes (24)

• Subjective Effects - Strong Flavor (Combinations 1-5)

  Strong flavor will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating a stronger perceived flavor.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Harshness/Irritancy (Combinations 1-5)

  Harshness/irritancy will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating harsher/more irritating effects.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Throat Hit (Combinations 1-5)

  Throat hit will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating a stronger throat hit.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Overall Like: Flavor (Combinations 1-5)

  Overall like: flavor will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the flavor was liked more.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Overall Like: Harshness (Combinations 1-5)

  Overall like: harshness will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the harshness was liked more.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Overall Like: Throat Hit (Combinations 1-5)

  Overall like: throat hit will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the throat hit was liked more.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Overall Like: Warmth (Combinations 1-5)

  Overall like: warmth will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the warmth was liked more.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Satisfying (Combinations 1-5)

  Satisfying will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater satisfaction.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Pleasant (Combinations 1-5)

  Pleasant will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater pleasantness.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Taste Good (Combinations 1-5)

  Taste good will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating better taste.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Calm (Combinations 1-5)

  Calm will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling calmer.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Concentrate (Combinations 1-5)

  Concentrate will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating better ability to concentrate.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Awake (Combinations 1-5)

  Awake will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling more awake/alert.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Reduce Hunger (Combinations 1-5)

  Reduce hunger will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater reduction in hunger.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Dizzy (Combinations 1-5)

  Dizzy will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater dizziness.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Feeling Sick (Combinations 1-5)

  Feeling sick will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling more sick.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Want it Right Now (Combinations 1-5)

  Want it right now will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating a stronger immediate desire for the product.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Smell (Combinations 1-5)

  Smell will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating a stronger perceived smell. This item is drawn from the Electronic Cigarette Specific Effects Questionnaire, a modified/expanded version of the modified Cigarette Evaluation Questionnaire (mCEQ; Cappelleri et al., 2007) developed for ENDS. Participants rate the item on a 0-10 scale immediately following each bout. Item wording: 'Did the e-cig produce a smell?' (0 = not at all, 10 = extremely).

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Visible Vapor (Combinations 1-5)

  Visible vapor will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating more visible vapor.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Importance Vapor (Combinations 1-5)

  Importance vapor will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating vapor visibility mattered more to the participant. This item is drawn from the Electronic Cigarette Specific Effects Questionnaire, a modified/expanded version of the modified Cigarette Evaluation Questionnaire (mCEQ; Cappelleri et al., 2007) developed for ENDS. Participants rate the item on a 0-10 scale immediately following each bout. Item wording: 'Is the vapor/cloud of the e-cig important to you?' (0 = not at all, 10 = extremely).

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Subjective Effects - Puffs Similar (Combinations 1-5)

  Puffs similar will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating the puffs were perceived as more similar to the participant's usual product.

  Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.

• Smoking Urges - Brief Factor 1 (Intention/Desire)

  Brief Factor 1 (Intention/Desire) will be assessed by the Questionnaire of Smoking Urges-Brief (QSU-Brief; Tiffany \& Drobes, 1991; Toll et al., 2006). Factor 1 is the sum of 6 items, each rated on a 0-10 scale (0=strongly disagree, 10=strongly agree), yielding a total score range of 0-60, with higher scores indicating stronger urges.

  Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).

• Smoking Urges - Brief Factor 2 (Relief of Neg. Affect)

  Brief Factor 2 (Relief of Neg. Affect) will be assessed by the Questionnaire of Smoking Urges-Brief (QSU-Brief; Tiffany \& Drobes, 1991; Toll et al., 2006). Factor 2 is the sum of 4 items, each rated on a 0-10 scale (0=strongly disagree, 10=strongly agree), yielding a total score range of 0-40, with higher scores indicating stronger urges.

  Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).

• Withdrawal Symptoms - Minnesota Nicotine Withdrawal Scale (MNWS; Based on Hughes and Hatsukami, 1986)

  The Minnesota Nicotine Withdrawal Scale (MNWS; based on Hughes and Hatsukami, 1986 questionnaire) was measured using composite mean of MNWS items (irritability, anxiety, difficulty concentrating, restlessness, hunger/appetite, Impatient, depression, desire for sweets and craving) on a 0-10 scale (Not at all - Extremely), with higher scores indicating greater withdrawal severity.

  Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).

Secondary Outcomes (11)

• Puff Duration

  Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout

• Number of Puffs

  Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout

• Puffing Time

  Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout

• Inter Puff Interval

  Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout

• Flow Rate

  Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout

Study Arms (8)

Combination One - 15μg/s protonated nicotine flux

EXPERIMENTAL

The investigators will test the subjective effects of nicotine flux (15μg/s) coupled with one ratio of nicotine form (100% protonated). Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout. One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum. Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.

Combination Product: e-liquid 1

Combination Two - 35μg/s protonated nicotine flux

EXPERIMENTAL

The investigators will test the subjective effects of nicotine flux (35μg/s) coupled with one ratio of nicotine form (100% protonated). Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout. One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum. Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.

Combination Product: e-liquid 2

Combination Three - 15μg/s free base nicotine flux

EXPERIMENTAL

The investigators will test the subjective effects of nicotine flux (15μg/s) coupled with one ratio of nicotine form (100% free base). Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout. One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum. Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.

Combination Product: e-liquid 3

Combination Four - 35μg/s free base nicotine flux

EXPERIMENTAL

The investigators will test the subjective effects of nicotine flux (35μg/s) coupled with one ratio of nicotine form (100% free base). Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout. One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum. Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.

Combination Product: e-liquid 4

Placebo - Combination Five - 0μg/s nicotine flux

PLACEBO COMPARATOR

The investigators will test the subjective effects of nicotine flux (0μg/s) placebo. Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout. One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum. Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.

Combination Product: e-liquid 5

Combination six - 0μg/s flux; high power/low power

EXPERIMENTAL

The investigators will test the subjective effects (perceived mouthful, perceived draw effort, and throat hit) at two power levels (20W and 40 W) with no nicotine in the liquid. Participants will alternate 10 directed puffs (30sec inter-puff interval) between two Subox Mini C devices differing only by the two power levels. Subjective measures will be administered following puff pairs 1\&2, 5\&6, and 9\&10.

Combination Product: e-liquid 6

Combination seven - 35μg/s flux; high power/low power

EXPERIMENTAL

The investigators will test the subjective effects (perceived mouthful, perceived draw effort, and throat hit) at two power levels (20W and 40 W) and a constant nicotine flux of 35 ug/s. Participants will alternate 10 directed puffs (30sec inter-puff interval) between two Subox Mini C devices (20 W; 8mg/ml and 40 W;4 mg/ml). Subjective measures will be administered following puff pairs 1\&2, 5\&6, and 9\&10.

Combination Product: e-liquid 7 and e-liquid 8

Combination eight - 15μg/s flux; high PG(propylene glycol)/VG(vegetable glycerin) / low PG/VG

EXPERIMENTAL

The investigators will test the subjective effects (perceived mouthful, perceived draw effort, and throat hit) at two propylene glycol/vegetable glycerin ratios (30/70 and 70/30). Participants will alternate 10 directed puffs (30sec inter-puff interval) between two Subox Mini C devices differing only by the two PG/VG ratios. Subjective measures will be administered following puff pairs 1\&2, 5\&6, and 9\&10.

Combination Product: e-liquid 9 and e-liquid 10

Interventions

e-liquid 1 COMBINATION_PRODUCT

30/70 propylene glycol/vegetable glycerin ratio with nicotine concentration 4mg/ml protonated

Combination One - 15μg/s protonated nicotine flux

e-liquid 2 COMBINATION_PRODUCT

30/70 PG/VG ratio with nicotine concentration 10mg/ml protonated

Combination Two - 35μg/s protonated nicotine flux

e-liquid 3 COMBINATION_PRODUCT

30/70 PG/VG ratio with nicotine concentration 4mg/ml free base

Combination Three - 15μg/s free base nicotine flux

e-liquid 4 COMBINATION_PRODUCT

30/70 PG/VG ratio with nicotine concentration 10mg/ml freebase

Combination Four - 35μg/s free base nicotine flux

e-liquid 5 COMBINATION_PRODUCT

30/70 PG/VG ratio with nicotine concentration 0mg/ml (placebo)

Placebo - Combination Five - 0μg/s nicotine flux

e-liquid 6 COMBINATION_PRODUCT

30/70 PG/VG ratio with nicotine concentration 0mg/ml

Combination six - 0μg/s flux; high power/low power

e-liquid 7 and e-liquid 8 COMBINATION_PRODUCT

e-liquid 7: 30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated e-liquid 8: 30/70 PG/VG ratio with nicotine concentration 8mg/ml protonated

Combination seven - 35μg/s flux; high power/low power

e-liquid 9 and e-liquid 10 COMBINATION_PRODUCT

e-liquid 9: 30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated e-liquid 10: 70/30 PG/VG ratio with nicotine concentration 4mg/ml protonated

Combination eight - 15μg/s flux; high PG(propylene glycol)/VG(vegetable glycerin) / low PG/VG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be healthy and above 18 years of age
• Must be willing to provide informed consent, attend the lab, and abstain from tobacco/nicotine as required (participants will be instructed to abstain from nicotine/tobacco and/or ENDS use for ≥12h)
• A dual ENDS and tobacco user who reports daily use of ENDS (≥ 3 mg/ml nicotine) or cigarettes (any frequency) AND someday use (≥ 3 days/week) of ENDS (≥ 3 mg/ml nicotine) or cigarettes (any frequency) for the past 3 months or longer

You may not qualify if:

• History of chronic disease or an uncontrolled psychiatric condition
• History of or active cardiovascular disease, low/high blood pressure, seizures, regular use of a prescription medication (except vitamins/birth control)
• Past month use of cocaine, opioids, benzodiazepines, or methamphetamines
• Individuals who report using marijuana \>15/30 days
• Women will be excluded if they are breast-feeding or pregnant
• Participants intending to quit tobacco/nicotine use in the next 30 days and referred to cessation treatment

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

American University of Beirut

Beirut, Beirut, 11-0236, Lebanon

Location

Related Publications (1)

• El-Hellani A, Hanna E, Sharma M, Blohowiak R, Joseph P, Eid T, Nadim H, El-Hage R, Salman R, Karaoghlanian N, Adeniji A, Salam S, Talih F, Elbejjani M, Breland A, Eissenberg T, Shihadeh A, Baldassarri SR, Talih S. Nicotine flux as a powerful tool for regulating nicotine delivery from e-cigarettes: Protocol of two complimentary randomized crossover clinical trials. PLoS One. 2023 Sep 21;18(9):e0291786. doi: 10.1371/journal.pone.0291786. eCollection 2023.

  PMID: 37733666 DERIVED

MeSH Terms

Conditions

Vaping; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Soha Talih
• Organization: American University of Beirut

st38@aub.edu.lb

9611350000

Study Officials

• Soha Talih, PhD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Each participant will attend the lab for five different visits that differ by nicotine flux and/or form in random order. All sessions will be double-blind (Participant / Investigator). The analytical chemist will be providing the investigator with e-liquid in a random order in each session for each participant.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will attend the lab for five different visits that differ by nicotine flux and/or form in random order.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 24, 2022
• Study Start: July 13, 2022
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: September 18, 2026
• Results First Posted: September 18, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)