drugset / Trial / NCT03134339

The Effect of Nicotine Delivery Rate on Reinforcement

NCT03134339

Phase 0 Completed 18 enrolled Yale University
RandomizedCrossoverDouble-blindBasic science

Summary

The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is necessary for accurately assessing dose-response and threshold effects. The estimated threshold for reinforcement will establish a benchmark for evaluating the addictive potential of ECs and other inhaled nicotine products.

Timeline

Start
2017-01-05
Primary completion
2018-01-29
Completion
2018-01-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 1 mg Intravenous

Indications