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Completed

NCT Number: NCT00563511

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

HKFPA, Hong Kong, China

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adherence intervention

Procedure

intervention without adherence advice

Procedure

Control

Procedure

Primary outcomes

  1. quit rate

    Time frame: 6-month

  2. adherence rate

    Time frame: 4-weeks after the first use of NRT

Secondary outcomes

  1. erectile function

    Time frame: 6-month

  2. use of NRT

    Time frame: 3-month

  3. quit rate

    Time frame: 3-month

Sponsors and collaborators

Lead sponsor

Hospital Authority, Hong Kong

Other Gov

Collaborators

  • The University of Hong Kong

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Nov 26, 2007
Registry last updated
Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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