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

Primary Purpose

Nicotine Vaping, Nicotine Dependence, Nicotine Addiction

Status

Recruiting

Phase

Not Applicable

Locations

Lebanon

Study Type

Interventional

Intervention

e-liquid 1

e-liquid 2

e-liquid 3

e-liquid 4

e-liquid 5

About this trial

This is an interventional other trial for Nicotine Vaping focused on measuring Nicotine, Nicotine Flux, Vaping, ENDS, Aerosol, Combustible

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

American University of BeirutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Combination One - 16μg/s protonated nicotine flux

Combination Two - 32μg/s protonated nicotine flux

Combination Three - 16μg/s free base nicotine flux

Combination Four - 32μg/s free base nicotine flux

Placebo - Combination Five - 0μg/s nicotine flux

Arm Description

The investigators will test the subjective effects of nicotine flux (16μg/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.

The investigators will test the subjective effects of nicotine flux (32μg/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.

The investigators will test the subjective effects of nicotine flux (16μg/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.

The investigators will test the subjective effects of nicotine flux (32μg/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.

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.

Outcomes

Primary Outcome Measures

Subjective Measures of Nicotine Abstinence Symptoms - PROMIS-10 Global Health measures

The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. 10 Items are rated on a five-point scale (Poor=1, Fair=2, Good=3, Very good=4, Excellent=5) with higher scores indicating higher activity.

Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item E-Cigarette Dependence

The corresponding 4-item E-Cigarette Dependence Scale that assesses dependence on ENDS. 4 Items are rated on a five-point scale (Never=1, Rarely=2, Sometimes=3, Often=4, Almost Always=5) with higher scores indicating higher activity.

Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item Combustible cigarette Dependence

The corresponding 4-item Combustible cigarette Dependence Scale that assesses nicotine dependence for daily and nondaily smokers. 4 Items are rated on a five-point scale (Never=1, Rarely=2, Sometimes=3, Often=4, Always=5) with higher scores indicating higher activity.

Nicotine Dependence questionnaires - The Fagerstrom Test of Nicotine Dependence

The Fagerstrom Test of Nicotine Dependence questionnaires that assesses nicotine dependence on ENDS. General questions not based on a scale.

Subjective Measures of Nicotine Abstinence Symptoms - Product liking magnitude scale

Product liking will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-100, not at all - extremely), with higher scores indicating higher effects.

Subjective Measures of Nicotine Abstinence Symptoms - Product liking hedonic scale

Product liking will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) (0-100, most disliked sensation imaginable - most liked sensation imaginable), with higher scores indicating higher effects.

Subjective Measures of Nicotine Abstinence Symptoms - Drug Effect

The Drug Effect Questionnaire (DEQ) will measure acute effects consisting of seven items: drug strength, high, feeling stimulated, good effects, bad effects, wanting more drugs, and drug liking and this will be assessed on a subjective scale (0-100, not at all-extremely), with higher scores indicating higher effects.

Subjective Measures of Nicotine Abstinence Symptoms - Smoking urges

Smoking urges will be assessed by the smoking urges questionnaire on a subjective scale (0-100, Strongly disagree - strongly agree) with higher scores indicating higher urges.

Subjective Measures of Nicotine Abstinence Symptoms - Hughes and Hatsukami

The Hughes-Hatsukami Withdrawal Questionnaire (HHWQ) will be assessed by the Hughes and Hatsukami 1986 questionnaire on a subjective scale (0-100, Not at all - extremely).

Secondary Outcome Measures

Puff Duration

Measured topography Average Puff Duration (sec).

Flow rate

Measured topography Average Flow rate (LPM).

Puff Interval

Measured topography Average Inter Puff Interval (sec).

Number of Puffs

Measured topography Total Number of Puffs (puffs).

Liquid consumed

Liquid consumption for each participant use session will be determined by pre- and post-weighing the ENDS device tank (g/session).

Carbonyl compound yield

Total Carbonyls Compounds will be quantified (microg/session).

Nicotine flux

Nicotine flux will be quantified (mg/sec).

Full Information

NCT ID

NCT05430334

First Posted

June 8, 2022

Last Updated

August 8, 2022

Sponsor

American University of Beirut Medical Center

Collaborators

National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT05430334

Brief Title

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

Official Title

Nicotine Flux, a Potentially Powerful Tool for Regulating Nicotine Delivery From Electronic Cigarettes: Significance of Nicotine Flux to the Rate of Nicotine Delivery and Subjective Effect

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 13, 2022 (Actual)

Primary Completion Date

June 13, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American University of Beirut Medical Center

Collaborators

National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Assess the influence of nicotine flux and nicotine form on subjective effects. At AUB, the investigators will assess subjective effects (e.g. product liking, nicotine craving) and puffing topography for 130 participants who will undergo 5 ENDS use sessions consisting of 2 bouts (10 puffs + 60min ad libitum) with 2 fluxes (16 and 32μg/s) x 2 forms (protonated, freebase) and a 0 nicotine condition. In addition, the investigators will use a state-of-the-art device to sample in situ a fraction of the aerosol generated during each puff to verify actual nicotine flux and form, and measure exposure to pulmonary toxicants (carbonyls). The investigators hypothesize that increasing nicotine flux and protonated nicotine will result in greater reductions of nicotine craving, and lower puffing intensity and carbonyl exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Vaping, Nicotine Dependence, Nicotine Addiction

Keywords

Nicotine, Nicotine Flux, Vaping, ENDS, Aerosol, Combustible

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combination One - 16μg/s protonated nicotine flux

Arm Type

Experimental

Arm Description

Arm Title

Combination Two - 32μg/s protonated nicotine flux

Arm Type

Experimental

Arm Description

Arm Title

Combination Three - 16μg/s free base nicotine flux

Arm Type

Experimental

Arm Description

Arm Title

Combination Four - 32μg/s free base nicotine flux

Arm Type

Experimental

Arm Description

Arm Title

Placebo - Combination Five - 0μg/s nicotine flux

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

e-liquid 1

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

e-liquid 2

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

e-liquid 3

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

e-liquid 4

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

e-liquid 5

Intervention Description

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

Primary Outcome Measure Information:

Title

Subjective Measures of Nicotine Abstinence Symptoms - PROMIS-10 Global Health measures

Description

Time Frame

Visit 1 - Before starting the first session

Title

Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item E-Cigarette Dependence

Description

Time Frame

Visit 1 - Before starting the first session

Title

Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item Combustible cigarette Dependence

Description

Time Frame

Visit 1 - Before starting the first session

Title

Nicotine Dependence questionnaires - The Fagerstrom Test of Nicotine Dependence

Description

The Fagerstrom Test of Nicotine Dependence questionnaires that assesses nicotine dependence on ENDS. General questions not based on a scale.

Time Frame

Visit 1 - Before starting the first session

Title

Subjective Measures of Nicotine Abstinence Symptoms - Product liking magnitude scale

Description

Time Frame

Up to 180 minutes

Title

Subjective Measures of Nicotine Abstinence Symptoms - Product liking hedonic scale

Description

Time Frame

Up to 180 minutes

Title

Subjective Measures of Nicotine Abstinence Symptoms - Drug Effect

Description

Time Frame

Up to 180 minutes

Title

Subjective Measures of Nicotine Abstinence Symptoms - Smoking urges

Description

Smoking urges will be assessed by the smoking urges questionnaire on a subjective scale (0-100, Strongly disagree - strongly agree) with higher scores indicating higher urges.

Time Frame

Up to 180 minutes

Title

Subjective Measures of Nicotine Abstinence Symptoms - Hughes and Hatsukami

Description

The Hughes-Hatsukami Withdrawal Questionnaire (HHWQ) will be assessed by the Hughes and Hatsukami 1986 questionnaire on a subjective scale (0-100, Not at all - extremely).

Time Frame

Up to 180 minutes

Secondary Outcome Measure Information:

Title

Puff Duration

Description

Measured topography Average Puff Duration (sec).

Time Frame

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

Title

Flow rate

Description

Measured topography Average Flow rate (LPM).

Time Frame

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

Title

Puff Interval

Description

Measured topography Average Inter Puff Interval (sec).

Time Frame

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

Title

Number of Puffs

Description

Measured topography Total Number of Puffs (puffs).

Time Frame

Will be measured during the approximately 60-minute, ad lib use bout

Title

Liquid consumed

Description

Liquid consumption for each participant use session will be determined by pre- and post-weighing the ENDS device tank (g/session).

Time Frame

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

Title

Carbonyl compound yield

Description

Total Carbonyls Compounds will be quantified (microg/session).

Time Frame

Will be measured after the 60-minute, ad lib use bout

Title

Nicotine flux

Description

Nicotine flux will be quantified (mg/sec).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Soha Talih, PhD

Phone

+961-1-350000

Ext

3627

st38@aub.edu.lb

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soha Talih, PhD

Organizational Affiliation

American University of Beirut Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

American University of Beirut

City

Beirut

ZIP/Postal Code

11-0236

Country

Lebanon

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Soha Talih

Phone

+9611350000

Ext

3627

st38@aub.edu.lb

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Participants data will not be available to other researchers

Learn more about this trial

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

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