Last reviewed · How we verify

NCT02102100

The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users

Completed NA Results posted Last updated 19 March 2020
What this trial tests

NA trial testing nicotine in Nicotine Dependence in 57 participants. Completed in 11 July 2016.

Timeline
26 March 2014
Primary endpoint
11 July 2016
11 July 2016

Quick facts

Lead sponsorYale University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment57
Start date26 March 2014
Primary completion11 July 2016
Estimated completion11 July 2016
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

Adults 18 to 30, any sex, with Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' Primary · up to 55 minutes post-infusion

The Drug Effects Questionnaire (DEQ) is used in studies of acute subjective response (SR) to a variety of substances. The DEQ consists of 11 questions: cooling effect, dislike the sensation, any sensations, feel a drug effect, high, feel stimulated, feel a head rush, like drug effect, dislike any effects, craving a cigarette, and like more of the drug. To calculate the DEQ- 'Good Drug Effects', peak values from post-infusion time points were calculated for the change in the intensity of positive subjective effects as measured with 2 DEQ questions - DEQ question #6 'like drug effect' and DEQ qu

Across Conditions (main effect)
GroupValue95% CI
Menthol-Preferring Smokers5.1979± 0.3803
Non-Menthol Preferring Smokers6.8384± 0.4292
High Menthol w High Nicotine
GroupValue95% CI
Menthol-Preferring Smokers5.6235± 0.4731
Non-Menthol Preferring Smokers7.6285± 0.5287
High Menthol w Low Nicotine
GroupValue95% CI
Menthol-Preferring Smokers5.226± 0.4766
Non-Menthol Preferring Smokers7.4351± 0.5302
High Menthol w Saline
GroupValue95% CI
Menthol-Preferring Smokers5.0699± 0.4768
Non-Menthol Preferring Smokers7.6285± 0.5287
Low Menthol w High Nicotine
GroupValue95% CI
Menthol-Preferring Smokers5.8971± 0.4736
Non-Menthol Preferring Smokers7.5808± 0.5346
Low Menthol w Low Nicotine
GroupValue95% CI
Menthol-Preferring Smokers5.5481± 0.4809
Non-Menthol Preferring Smokers6.7656± 0.5363
Low Menthol w Saline
GroupValue95% CI
Menthol-Preferring Smokers4.4655± 0.4741
Non-Menthol Preferring Smokers6.3960± 0.5307

Sponsor's own description

This study will help determine if menthol administered by inhalation via electronic cigarettes (e-cigarette) changes the reinforcing effects of pure nicotine administered intravenously in cigarette smokers who smoke mentholated or non-mentholated cigarettes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of nicotine

Trials testing the same drug.

Other recruiting trials for Nicotine Dependence

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02102100.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing