Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

Early Phase 1

Completed

• Conditions: Nicotine Dependence
• Interventions: Drug: Nicotine infusion 0.096mcg/kg/s; Drug: Nicotine infusion 0.24mcg/kg/s; Drug: Nicotine saline infusion 0.00mcg/kg/s; Drug: Nicotine infusion 0.048 mcg/kg/s; Drug: Nicotine infusion 0.024mcg/kg/s

• Registration Number: NCT03580525
• Lead Sponsor: Yale University

Brief 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."

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-09
• Study Start: 2019-02-14
• Primary Completion: 2020-11-19
• Study Completion: 2020-11-19
• Results First Submitted: 2022-07-27
• Results First Submitted QC: 2023-09-08
• Results First Posted: 2023-10-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nicotine infusion 0.096mcg/kg/s	Nicotine infusion 0.096mcg/kg/s	0.096mcg/kg/s The day order will be randomized per day
nicotine infusion 0.24mcg/kg/s	Nicotine infusion 0.24mcg/kg/s	0.24mcg/kg/s The day order will be randomized per day
nicotine saline infusion 0.00mcg/kg/s	Nicotine saline infusion 0.00mcg/kg/s	0.00 mcg/kg/s The day order will be randomized per day
nicotine infusion 0.048mcg/kg/s	Nicotine infusion 0.048 mcg/kg/s	0.048mcg/kg/s The day order will be randomized per day
nicotine infusion 0.024mcg/kg/s	Nicotine infusion 0.024mcg/kg/s	0.048mcg/kg/s The day order will be randomized per day

Primary Outcome Measures

Name	Time	Method
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Pleasurable Effects	up to 10 minutes post infusion	The peak change in the intensity of subjective effects as measured by the DEQ: Drug pleasurable effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects	up to 10 minutes	The peak change in the intensity of subjective effects as measured by the DEQ: Drug stimulatory effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.

Trial Locations

Locations (1)

Veterans Affairs Hospital; 🇺🇸 West Haven, Connecticut, United States