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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02949648
Other study ID # EC use and quitting in youth
Secondary ID
Status Completed
Phase N/A
First received May 19, 2016
Last updated October 27, 2016
Start date September 2015
Est. completion date August 2016

Study information

Verified date October 2016
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Observational

Clinical Trial Summary

A mixed method (longitudinal, trajectory and qualitative studies) to provide comprehensive evidence on the impact of e-cigarette use on smoking and quitting among smoking youth in Hong Kong.


Description:

Subjects are from a cohort of Youth Quitline callers and smoking youth (N=200) in Hong Kong. The longitudinal study will investigate the effects of baseline e-cigarette use on quitting (including relapse), nicotine addiction and intention to smoke at 12-month telephone follow-up. A qualitative study will be conducted on 10 ex- and 10 current smokers to supplement and facilitate interpretation of the quantitative findings.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date August 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 25 Years
Eligibility Inclusion Criteria:

1. Ethnic Chinese

2. Cantonese speakers

3. Smoke at least 1 cigarette in the past 30 days

Exclusion Criteria:

1. Psychologically or physically unable to communicate

2. Undergoing other smoking cessation programme

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Electronic cigarette
Electronic cigarettes are devices that do not burn or use tobacco leaves but instead vaporize a solution the user then inhales. The device contains an electronic vaporization system, rechargeable batteries, electronic controls and cartridges of the liquid is vaporized.

Locations

Country Name City State
Hong Kong Youth Quitline, School of Nursing, The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 7-day point prevalence abstinence assessed in the telephone follow-up survey Self-reported 7-day point prevalence abstinence (PPA) is a validated, commonly used measure of smoking cessation. Subjects who reports no smoking in the preceding 7 days at the time of 12-month survey in the follow-up are regarded as quitters.
This measure has serval advantages compared to continuous abstinence. First, it can include smokers who take delayed action and quit. It also allows relapses to occur in the follow up period, without classifying smokers as permanent failure. Third, it does not rely on recall of past events happened long ago.
12 months after baseline survey No
Secondary Quit attempts assessed in the telephone follow-up survey Smokers report how many times they try to abstain from cigarette for more than 24 hours in the whole follow-up period 12 months after baseline survey No
Secondary Intention to quit assessed in the telephone follow-up survey Smokers report whether they intend to quit smoking at the time of 12-month survey in the follow-up 12 months after baseline survey No
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