NCT03580525

Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).

Detailed description

A placebo-controlled study that will enroll male and female tobacco smokers' menthol to participate in five experimental sessions. During the experimental session, subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec). The infusion conditions for each experimental session will be determined in random order. Aim 1 is to establish a dose-effect curve for positive subjective effects (drug liking and good drug effects) and alleviation of smoking urges, as a function of nicotine delivery rate in menthol and non-menthol cigarette preferring smokers Aim 2 is to establish a dose-effect curve positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate. Aim 3 is to establish a dose-effect curve for nicotine's effect to alleviate symptoms of nicotine withdrawal in abstinent smokers as a function of nicotine delivery rate. Aim 4 is to establish a dose-effect curve for nicotine's acute cardiovascular health effects. Data from this project will help to establish benchmark values for nicotine's threshold effects that will guide policies on the nicotine yield of tobacco products. Presented is the time frame at which the peak change was strongest by treatment arm. The possible peak numbers could be 1, 3, 5, 7 and 10 minutes."

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Nicotine saline infusion 0.00mcg/kg/s	saline 0.00mcg/kg/s
DRUG	Nicotine infusion 0.24mcg/kg/s	nicotine 0.24mcg/kg/s
DRUG	Nicotine infusion 0.096mcg/kg/s	nicotine 0.096mcg/kg/s
DRUG	Nicotine infusion 0.048 mcg/kg/s	nicotine 0.048mcg/kg/s
DRUG	Nicotine infusion 0.024mcg/kg/s	nicotine 0.024mcg/kg/s

Timeline

• Start date: 2019-02-14
• Primary completion: 2020-11-19
• Completion: 2020-11-19
• First posted: 2018-07-09
• Last updated: 2024-03-12
• Results posted: 2023-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study