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Smoking Cessation and Sexual Health in Men

Smoking Cessation Clinical Trial

Official title:
Effects of Smoking Cessation on Sexual Health in Men

Clinical Trial Summary

This is a 12-week clinical trial investigating the effects of smoking cessation on sexual functioning in men. This study consists of 3 sessions and provides 8 weeks of free nicotine transdermal patches. It is hypothesized that men who quit smoking, compared to men who smoke as usual, will demonstrate improved sexual functioning, measured both physiologically (erectile functioning) and subjectively (self-reported sexual functioning).

Clinical Trial Description

Objective: Tobacco use constitutes the single most preventable cause of disease and death in the world today and is responsible for introducing a number of diseases including many types of cancer, cardiovascular diseases, and respiratory diseases. Extensive literature indicates that cigarette smoking is an independent risk factor for introducing erectile impairment in men. Controlled clinical trials examining the effects of smoking cessation on sexual functioning are necessary in order to investigate whether quitting smoking improves sexual health.

Design: This is a 12-week clinical trial in which 80 male long-term smokers will be tested at baseline (while smoking) and then randomized to an 8-week nicotine patch treatment regimen (n = 50) or to a delayed treatment wait list condition (n = 30). All participants will be reassessed at mid-treatment (4 weeks), and at 1-month follow-up.

Main Outcome Measures: Physiological (penile circumferential change via penile plethysmography), and subjective (continuous self-report) sexual responses to erotic stimuli will be examined, as well as global changes in self-reported sexual functioning.

Implications: If participants do in fact demonstrate a significant increase in sexual arousal and sexual functioning as a result of smoking cessation, these results may have the potential for facilitating programs and interventions targeting the prevention and cessation of cigarette smoking in men. This would alleviate enormous economic burdens caused by erectile dysfunction and other smoking-related diseases. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00833404
Study type Interventional
Source University of Texas at Austin
Contact
Status Completed
Phase Phase 1
Start date December 2008
Completion date December 2010
View Details
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