NCT02294617

Brief Summary

The goal of this study is to get information from current smokers about how they feel towards both the electronic cigarette (e-cigarette) and the nicotine oral inhaler. This will include beliefs, harms, appeal, ease of use, enjoyment, and their use for helping people stop smoking.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 13, 2025

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

June 23, 2014

Last Update Submit

April 9, 2025

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • Satisfaction of devices on Likert Scale

    The goal of this study is to gather data from current smokers regarding their perceptions and experiences with both the e-cigarette and the nicotine oral inhaler over a 6 month time period.

    6 months (August 2012-December 2013)

Study Arms (2)

Nicotrol Inhaler

ACTIVE COMPARATOR

Subjects will use the Nicotine Inhaler for 3 days.

Other: Nicotrol Inhaler

Electronic Cigarette

ACTIVE COMPARATOR

Subject will use the electronic cigarette for 3 days.

Other: Electronic Cigarette

Interventions

Electronic CigaretteOTHER

Subject will use electronic cigarette for 3 days.

Electronic Cigarette
Nicotrol InhalerOTHER

Subjects will use the Nicotrol Inhaler for 3 days.

Nicotrol Inhaler

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be smokers 18 years or older, who have had no previous experience with either the e-cigarette or the nicotine oral inhaler, and will be recruited from the local community. They can currently smoke any amount or frequency and with any level of motivation to stop smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking

Interventions

Electronic Nicotine Delivery SystemsNicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and AgricultureSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 23, 2014

First Posted

November 19, 2014

Study Start

August 1, 2012

Primary Completion

April 1, 2014

Study Completion

January 1, 2015

Last Updated

April 13, 2025

Record last verified: 2014-11