A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction

This study has been completed.

First Received: November 21, 2007 Last Updated: June 23, 2009 History of Changes

Sponsors and Collaborators:	Hospital Authority, Hong Kong Dept of Community Medicine, HKU
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00563511

Purpose

The purpose of this proposed RCT is to test (a) the effectiveness of smoking cessation intervention (counseling and NRT) among patients with ED; and (b) the effectiveness of adherence intervention (ADIN) to increase adherence to NRT use in order to increase quit rate.

Condition	Intervention
Smoking Cessation	Procedure: adherence intervention Procedure: intervention without adherence advice Procedure: control

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

quit rate [ Time Frame: 6-month ]
adherence rate [ Time Frame: 4-weeks after the first use of NRT ]

Secondary Outcome Measures:

erectile function [ Time Frame: 6-month ]
use of NRT [ Time Frame: 3-month ]
quit rate [ Time Frame: 3-month ]

Estimated Enrollment:	1210
Study Start Date:	January 2004
Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male

Criteria

Inclusion Criteria:

Male ethnic Chinese aged 18 or above
Smokes at least 1 cigarette per day
Is not following other forms of smoking cessation interventions
Intends to quit smoking within the next 7 days of the first contact and would use NRT
Free from illness that contraindicate to the use of NRT
Has signed an informed consent form, or has given verbal consent (for those contacted by telephone)

Exclusion Criteria:

Patients who are psychologically or physically unable to communicate
Children and teenagers (aged below 18)
Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563511

Locations

China
Kwong Wah Hospital
Hong Kong, China
HKFPA
Hong Kong, China
The University of Hong Kong
Hong Kong, China
WHO
Hong Kong, China

Sponsors and Collaborators

Hospital Authority, Hong Kong

Dept of Community Medicine, HKU

Investigators

Principal Investigator:

TH Lam, Prof

Department of Community Medicine, The University of Hong Kong

More Information

Additional Information:

Hong Kong: Ethics Committee This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	EC1966-02, HARECCTR0500052, HKU7428/03M
Study First Received:	November 21, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00563511 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

smoking cessation

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Smoking
Sexual Dysfunction, Physiological

Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Habits
Smoking
Sexual Dysfunction, Physiological

Mental Disorders
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction

ClinicalTrials.gov processed this record on September 10, 2009