Abuse liability assessment of the JUUL system in two nicotine concentrations compared to combustible cigarette, nicotine gum and comparator electronic nicotine delivery system

•Abuse liability of the JUUL System (JS) in 5.0 % and 3.0 % nicotine was assessed.•Comparators included combustible cigarette, 4 mg nicotine gum and VUSE Alto (5.0 %).•Abuse liability of both JS is lower than cigarettes and higher than nicotine gum.•Abuse liability of JS 5.0 % is somewhat higher tha...

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Veröffentlicht in:Drug and alcohol dependence 2020-12, Vol.217, p.108441, Article 108441
Hauptverfasser: Goldenson, Nicholas I., Buchhalter, August R., Augustson, Erik M., Rubinstein, Mark L., Van Hoof, Dennis, Henningfield, Jack E.
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container_end_page
container_issue
container_start_page 108441
container_title Drug and alcohol dependence
container_volume 217
creator Goldenson, Nicholas I.
Buchhalter, August R.
Augustson, Erik M.
Rubinstein, Mark L.
Van Hoof, Dennis
Henningfield, Jack E.
description •Abuse liability of the JUUL System (JS) in 5.0 % and 3.0 % nicotine was assessed.•Comparators included combustible cigarette, 4 mg nicotine gum and VUSE Alto (5.0 %).•Abuse liability of both JS is lower than cigarettes and higher than nicotine gum.•Abuse liability of JS 5.0 % is somewhat higher than JS 3.0 %.•Abuse liability of JS 5.0 % and 3.0 % is somewhat lower than VUSE Alto 5.0 %. To assess the abuse liability of the JUUL System (JS) in 5.0 % (59 mg/mL) and 3.0 % (35 mg/mL) nicotine concentrations. Adult smokers (N = 146; 45.9 % female; mean age = 41.29 years) were randomized to one of four study flavor arms and then to a within-subjects cross-over sequence for five test product categories: (1) JS 5.0 % nicotine concentration; (2) JS 3.0 % nicotine; (3) usual brand (UB) cigarette; (4) 4 mg mint nicotine gum; (5) comparator ENDS (VUSE Alto 5.0 % nicotine). Products were tested by ad libitum use (5 min for ENDS and cigarette; 30 min for gum); nicotine pharmacokinetic (PK) parameters and subjective effects were assessed following use. Maximum plasma nicotine concentration (Cmax-BL), rate of plasma nicotine rise and total nicotine exposure (AUC0–60-BL) of UB cigarette were significantly greater than all other test products. The comparator ENDS was significantly greater than 5.0 % and 3.0 % JS and nicotine gum on Cmax-BL, rate of plasma nicotine rise, and AUC0–60-BL; Cmax-BL of JS 5.0 % was significantly greater than JS 3.0 % and nicotine gum. Product liking and satisfying effects were significantly highest for the UB cigarette; JS products and comparator ENDS did not significantly differ and were rated higher than nicotine gum on most subjective measures. These results suggest that the abuse liability of both 5.0 % and 3.0 % JS is: (1) substantially lower than UB cigarette; (2) somewhat lower than comparator ENDS; and (3) higher than nicotine gum. Additionally, the abuse liability of JS 5.0 % is somewhat higher than JS 3.0 %.
doi_str_mv 10.1016/j.drugalcdep.2020.108441
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To assess the abuse liability of the JUUL System (JS) in 5.0 % (59 mg/mL) and 3.0 % (35 mg/mL) nicotine concentrations. Adult smokers (N = 146; 45.9 % female; mean age = 41.29 years) were randomized to one of four study flavor arms and then to a within-subjects cross-over sequence for five test product categories: (1) JS 5.0 % nicotine concentration; (2) JS 3.0 % nicotine; (3) usual brand (UB) cigarette; (4) 4 mg mint nicotine gum; (5) comparator ENDS (VUSE Alto 5.0 % nicotine). Products were tested by ad libitum use (5 min for ENDS and cigarette; 30 min for gum); nicotine pharmacokinetic (PK) parameters and subjective effects were assessed following use. Maximum plasma nicotine concentration (Cmax-BL), rate of plasma nicotine rise and total nicotine exposure (AUC0–60-BL) of UB cigarette were significantly greater than all other test products. The comparator ENDS was significantly greater than 5.0 % and 3.0 % JS and nicotine gum on Cmax-BL, rate of plasma nicotine rise, and AUC0–60-BL; Cmax-BL of JS 5.0 % was significantly greater than JS 3.0 % and nicotine gum. Product liking and satisfying effects were significantly highest for the UB cigarette; JS products and comparator ENDS did not significantly differ and were rated higher than nicotine gum on most subjective measures. These results suggest that the abuse liability of both 5.0 % and 3.0 % JS is: (1) substantially lower than UB cigarette; (2) somewhat lower than comparator ENDS; and (3) higher than nicotine gum. 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To assess the abuse liability of the JUUL System (JS) in 5.0 % (59 mg/mL) and 3.0 % (35 mg/mL) nicotine concentrations. Adult smokers (N = 146; 45.9 % female; mean age = 41.29 years) were randomized to one of four study flavor arms and then to a within-subjects cross-over sequence for five test product categories: (1) JS 5.0 % nicotine concentration; (2) JS 3.0 % nicotine; (3) usual brand (UB) cigarette; (4) 4 mg mint nicotine gum; (5) comparator ENDS (VUSE Alto 5.0 % nicotine). Products were tested by ad libitum use (5 min for ENDS and cigarette; 30 min for gum); nicotine pharmacokinetic (PK) parameters and subjective effects were assessed following use. Maximum plasma nicotine concentration (Cmax-BL), rate of plasma nicotine rise and total nicotine exposure (AUC0–60-BL) of UB cigarette were significantly greater than all other test products. 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To assess the abuse liability of the JUUL System (JS) in 5.0 % (59 mg/mL) and 3.0 % (35 mg/mL) nicotine concentrations. Adult smokers (N = 146; 45.9 % female; mean age = 41.29 years) were randomized to one of four study flavor arms and then to a within-subjects cross-over sequence for five test product categories: (1) JS 5.0 % nicotine concentration; (2) JS 3.0 % nicotine; (3) usual brand (UB) cigarette; (4) 4 mg mint nicotine gum; (5) comparator ENDS (VUSE Alto 5.0 % nicotine). Products were tested by ad libitum use (5 min for ENDS and cigarette; 30 min for gum); nicotine pharmacokinetic (PK) parameters and subjective effects were assessed following use. Maximum plasma nicotine concentration (Cmax-BL), rate of plasma nicotine rise and total nicotine exposure (AUC0–60-BL) of UB cigarette were significantly greater than all other test products. 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source Applied Social Sciences Index & Abstracts (ASSIA); MEDLINE; Elsevier ScienceDirect Journals
subjects Abuse
Abuse liability
Adult
Cigarette
Cigarettes
Cross-Over Studies
Electronic nicotine delivery system
Electronic Nicotine Delivery Systems
Female
Flammability
Flavor
Flavoring Agents
Humans
JUUL
Liability
Liking
Male
Nicotine
Nicotine - blood
Nicotine Chewing Gum
Nicotine gum
Pharmacokinetics
Smokers
Subjective effects
Taste
Tobacco Products
Tobacco Use Disorder
title Abuse liability assessment of the JUUL system in two nicotine concentrations compared to combustible cigarette, nicotine gum and comparator electronic nicotine delivery system
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