CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 26 enrolled
Drug / intervention
IV nicotine +3 moredrug
Likely dose
IV nicotine 0.25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03243630
NCT03243630Early Ph 1Completed
CompareCT.gov

Effects of Flavors on Nicotine Reinforcement in Smokers

Yale University·interventional·Posted Aug 9, 2017·Updated Dec 3, 2020

In Brief

A Early Phase 1 clinical trial evaluating IV nicotine, Menthol flavor, and 2 other interventions for Nicotine Dependence. Completed, enrolled 26 participants across 1 site.

Detailed Summary

To examine the acute reinforcing effects of menthol, a fruit flavor (green apple) or a fruit flavor plus menthol, alone or in combination with nicotine in smokers. Flavors will be administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine will be administered intravenously. The reinforcing drug effects will be measured with the drug effects questionnaire (DEQ).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 9, 2017
Enrollment StartApr 23, 2018
Primary CompletionDec 19, 2018
Study CompletionJan 31, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.9 years ago

Interventions

IV nicotinedrug

Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg

Menthol flavordrug

American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator

green appledrug

green apple will be added to the menthol flavor

green apple and mentholdrug

menthol and green apple will be the active intervention