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NCT00563511 Clinical Trial

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

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00563511
Other study ID # EC1966-02
Secondary ID HARECCTR0500052H
Status Completed
Phase N/A
First received November 21, 2007
Last updated June 15, 2011
Start date January 2004
Est. completion date August 2006

Study information
Verified date June 2011
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1210
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Procedure:
• adherence intervention

• intervention without adherence advice

• control

Locations
Country Name City State
China HKFPA Hong Kong
China Kwong Wah Hospital Hong Kong
China The University of Hong Kong Hong Kong
China WHO Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary quit rate 6-month
Primary adherence rate 4-weeks after the first use of NRT
Secondary erectile function 6-month
Secondary use of NRT 3-month
Secondary quit rate 3-month
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