CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 24 enrolled
Drug / intervention
Nicotine saline infusion 0.00mcg/kg/s +4 moredrug
Likely dose
Nicotine saline infusion 0.00mcg/kg/sfrom 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/NCT03580525
NCT03580525Early Ph 1Completed
CompareCT.gov

Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

Yale University·interventional·Posted Jul 9, 2018·Updated Mar 12, 2024

In Brief

A Early Phase 1 clinical trial evaluating Nicotine saline infusion 0.00mcg/kg/s, Nicotine infusion 0.24mcg/kg/s, and 3 other interventions for Nicotine Dependence. Completed, enrolled 24 participants across 1 site.

Detailed 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).

Study Details

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

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedJul 9, 2018
Enrollment StartFeb 14, 2019
Primary CompletionNov 19, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.0 years ago

Interventions

Nicotine saline infusion 0.00mcg/kg/sdrug

saline 0.00mcg/kg/s

Nicotine infusion 0.24mcg/kg/sdrug

nicotine 0.24mcg/kg/s

Nicotine infusion 0.096mcg/kg/sdrug

nicotine 0.096mcg/kg/s

Nicotine infusion 0.048 mcg/kg/sdrug

nicotine 0.048mcg/kg/s

Nicotine infusion 0.024mcg/kg/sdrug

nicotine 0.024mcg/kg/s