MedTrace Logo

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

NCT02102100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2020-03-19

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Nicotine Dependence

Interventions

DRUG

nicotine

In each of 3 test sessions, subjects in each arm will receive a randomized sequence of three intravenous infusions (30 sec each), one hour apart. The infusions will consist of saline, nicotine (.25 mg / 70kg) and nicotine (0.5 mg / 70 kg). The randomized sequence will remain the same between test sessions for a given subject.

DRUG

menthol

In each of 3 test sessions, subjects will take 6 inhalations from the study e-cigarette, one inhalation every 15 seconds, of the randomized menthol condition for that test session ust prior to each intravenous infusion. The menthol conditions are: 3.2% menthol, 0.5% menthol and tobacco-flavor only (0.0% menthol)

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Mehmet Sofuoglu, MD, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-26
Primary Completion
2016-07-11
Completion
2016-07-11

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102100 on ClinicalTrials.gov