E-cigarette vs. Nicotine Inhaler Comparisons

Smoking Clinical Trial

Official title:

Comparative Evaluation of the Perceptions and Utilization of Nicotine Inhalation Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294617
• Other study ID #: P30CA072720
• Status: Completed
• Phase: N/A
• First received: June 23, 2014
• Last updated: November 14, 2014
• Start date: August 2012

Study information

• Verified date: November 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Subjects will be seen at Baseline, then 3-days post-baseline, then 9 days post-baseline for post product use questionnaires and carbon monoxide monitoring. The time frame for follow up is 6 months post Baseline visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Exclusion criteria include recent (within 2 weeks) myocardial infarction or angina, poorly controlled asthma/chronic obstructive pulmonary disease , active substance abuse, pregnancy, or current use of any other cessation medications

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• Electronic Cigarette
Subject will use electronic cigarette for 3 days.
• Nicotrol Inhaler
Subjects will use the Nicotrol Inhaler for 3 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceptions about devices	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)	No