Assess the Influence of Nicotine Flux and Nicotine Form on Subjective Effects Related to Dependency
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ClinicalTrials.gov Identifier: NCT05430334 |
Recruitment Status :
Recruiting
First Posted : June 24, 2022
Last Update Posted : December 8, 2023
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Condition or disease | Intervention/treatment | Phase |
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Nicotine Vaping Nicotine Dependence Nicotine Addiction | Combination Product: e-liquid 1 Combination Product: e-liquid 2 Combination Product: e-liquid 3 Combination Product: e-liquid 4 Combination Product: e-liquid 5 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Each participant will attend the lab for five different visits that differ by nicotine flux and/or form in random order. |
Masking: | Double (Participant, Investigator) |
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. |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | July 13, 2022 |
Estimated Primary Completion Date : | September 13, 2024 |
Estimated Study Completion Date : | January 31, 2025 |
Arm | Intervention/treatment |
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Experimental: Combination One - 16μg/s protonated nicotine flux
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.
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Combination Product: e-liquid 1
30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated |
Experimental: Combination Two - 32μg/s protonated nicotine flux
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.
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Combination Product: e-liquid 2
30/70 PG/VG ratio with nicotine concentration 10mg/ml protonated |
Experimental: Combination Three - 16μg/s free base nicotine flux
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.
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Combination Product: e-liquid 3
30/70 PG/VG ratio with nicotine concentration 4mg/ml free base |
Experimental: Combination Four - 32μg/s free base nicotine flux
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.
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Combination Product: e-liquid 4
30/70 PG/VG ratio with nicotine concentration 10mg/ml freebase |
Placebo Comparator: Placebo - Combination Five - 0μg/s nicotine flux
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.
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Combination Product: e-liquid 5
30/70 PG/VG ratio with nicotine concentration 0mg/ml (placebo) |
- Subjective Measures of Nicotine Abstinence Symptoms - PROMIS-10 Global Health measures [ Time Frame: Visit 1 - Before starting the first session ]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 [ Time Frame: Visit 1 - Before starting the first session ]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 [ Time Frame: Visit 1 - Before starting the first session ]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 [ Time Frame: Visit 1 - Before starting the first session ]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 [ Time Frame: Up to 180 minutes ]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 [ Time Frame: Up to 180 minutes ]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 [ Time Frame: Up to 180 minutes ]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 [ Time Frame: Up to 180 minutes ]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 [ Time Frame: Up to 180 minutes ]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).
- Puff Duration [ Time Frame: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout ]Measured topography Average Puff Duration (sec).
- Flow rate [ Time Frame: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout ]Measured topography Average Flow rate (LPM).
- Puff Interval [ Time Frame: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout ]Measured topography Average Inter Puff Interval (sec).
- Number of Puffs [ Time Frame: Will be measured during the approximately 60-minute, ad lib use bout ]Measured topography Total Number of Puffs (puffs).
- Liquid consumed [ Time Frame: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout ]Liquid consumption for each participant use session will be determined by pre- and post-weighing the ENDS device tank (g/session).
- Carbonyl compound yield [ Time Frame: Will be measured after the 60-minute, ad lib use bout ]Total Carbonyls Compounds will be quantified (microg/session).
- Nicotine flux [ Time Frame: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout ]Nicotine flux will be quantified (mg/sec).
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05430334
Contact: Soha Talih, PhD | +961-1-350000 ext 3627 | st38@aub.edu.lb |
Lebanon | |
American University of Beirut | Recruiting |
Beirut, Lebanon, 11-0236 | |
Contact: Soha Talih +9611350000 ext 3627 st38@aub.edu.lb |
Principal Investigator: | Soha Talih, PhD | American University of Beirut Medical Center |
Responsible Party: | American University of Beirut Medical Center |
ClinicalTrials.gov Identifier: | NCT05430334 |
Other Study ID Numbers: |
American University Of Beirut 1R01DA052565-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | June 24, 2022 Key Record Dates |
Last Update Posted: | December 8, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Participants data will not be available to other researchers |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Nicotine Nicotine Flux Vaping |
ENDS Aerosol Combustible |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |