Clinical Trials Logo
  1. Home
  2. Nicotine Dependence
  3. NCT03580525

Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

Nicotine Dependence Clinical Trial

Official title:
Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03580525
Study type Interventional
Source Yale University
Contact
Status Completed
Phase Early Phase 1
Start date February 14, 2019
Completion date November 19, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05176418 - IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate Early Phase 1
Completed NCT04084210 - Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use Phase 2
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Withdrawn NCT03707600 - State and Trait Mediated Response to TMS in Substance Use Disorder N/A
Recruiting NCT03999099 - Targeting Orexin to Treat Nicotine Dependence Phase 1
Completed NCT03847155 - Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery N/A
Completed NCT02840435 - Study on Sit to Quit Phone Intervention N/A
Completed NCT02139930 - Project 2: Strategies for Reducing Nicotine Content in Cigarettes N/A
Completed NCT01982110 - A Mindfulness Based Application for Smoking Cessation N/A
Completed NCT01926626 - Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers Phase 2
Completed NCT01685996 - Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation Phase 1/Phase 2
Completed NCT01569490 - Striving to Quit: First Breath N/A
Completed NCT01632189 - The Effect of Varenicline on D2/D3 Receptor Binding in Smokers N/A
Withdrawn NCT01569477 - Striving to Quit-Wisconsin Tobacco Quit Line N/A
Active, not recruiting NCT01182766 - New Treatment for Alcohol and Nicotine Dependence Phase 2/Phase 3
Completed NCT01061528 - Coping Skills Treatment for Smoking Cessation N/A
Completed NCT00996034 - Nicotine Vaccination and Nicotinic Receptor Occupancy Phase 2
Withdrawn NCT01589081 - Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect N/A
Suspended NCT01636336 - Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects N/A
Completed NCT01943994 - Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study N/A