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CompletedNCT00833404Updated Sep 12, 2011

Smoking Cessation and Sexual Health in Men

A Phase 1 interventional study of Nicotine transdermal patch in Smoking Cessation, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to male participants aged 23 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-09-12.

Sponsored by University of Texas at Austin · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
23 Years to 60 Years
Sex
Male
01

Study 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).

Read the detailed 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.

02

Conditions studied

  • Smoking Cessation

Keywords

  • Smoking
  • Smoking Cessation
  • Quit Smoking
  • Stop Smoking
  • Nicotine Patch
  • Nicotine Replacement Therapy
  • Sexual Functioning
  • Erectile Functioning
  • Sexual Health
03

In context

Lead sponsor

University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
23 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male
  • Between the ages of 25 and 60
  • Proficient in English
  • Currently smoke at least 15 cigarettes per day for at least 5 years
  • Heterosexual
  • Currently sexually active (sexual intercourse within the past 30 days)
  • Committed to quit smoking

Exclusion criteria

Exclusion Criteria:

  • History of HIV infection or active, untreated pelvic or urinary tract infection including, sexually transmitted diseases such as chlamydia genital herpes, gonorrhea, or syphilis.
  • Major pelvic surgery that may have caused nerve damage, or serious bladder, rectal, or abdominal surgery.
  • Neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
  • Clinically significant untreated renal or endocrine disease.
  • Uncontrolled hypotension or hypertension manifested by systolic blood pressure >170 or \<90 mm Hg or diastolic blood pressure >100 or \<50 mm Hg.
  • History of serious drug abuse or serious alcohol abuse within the past 12 months (>= 16 points on the Alcohol Use Disorders Identification Test (AUDIT) and >= 6 on the Drug Abuse Screening Test (DAST-10).
  • Evidence of schizophrenia, bipolar disorder, delusional disorder, or psychotic disorders not classified elsewhere as per the DSM-IV
  • Using medications known to affect sexual or vascular functioning, including antidepressants and anti-hypertensives, as well as sildenafil, vardenafil, tadalafil, or any other substance designed to affect sexual performance
  • Patients using insulin, narcotic pain relievers (propoxyphene, pentazocine), tricyclic antidepressants, oxazepam, or medications for respiratory diseases such as COPD or asthma (xanthines (e.g., theophylline) as these drugs are contraindicated by the nicotine patch
  • Patients who report experiencing clinically significant sexual difficulties, including hypoactive sexual desire disorder, sexual arousal disorder, premature ejaculation, or inhibited orgasm prior to the onset of smoking.
  • Recent myocardial infarction, serious heart arrhythmias, and those with serious or worsening angina.
  • Hypersensitivity or allergy to nicotine.
  • History of or current psoriasis, dermatitis (atopic or eczematous), active peptic ulcers, severe renal impairment, hyperthyroidism, pheochromocytoma, or insulin-dependent diabetes mellitus.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Smoking Cessation

    8-week nicotine patch regimen

    Drug: Nicotine transdermal patch

  • No intervention
    Wait List Control

    Smoking as usual

Interventions

  • DrugNicotine transdermal patch

    8-week nicotine patch regimen (21mg/day during week 1-4, 14mg/day during week 5-6, and 7mg/day during week 7-8).

    Also known as: Nicotine, Nicotine patch

06

What researchers measure

Primary outcomes

  1. Sexual functioning

    Time frame: Baseline, 4 weeks, 12 weeks

Secondary outcomes

  1. Cardiovascular health

    Time frame: Baseline, 4 weeks, 12 weeks

07

Study locations

1 site
  • University of Texas at Austin
    Austin, Texas 78712, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00833404
Lead sponsor
University of Texas at Austin
Responsible party
Christopher Harte, Ph.D. (Postdoctoral fellow, University of Texas at Austin) — Principal investigator
First posted
Feb 2, 2009
Start date
Dec 2008
Primary completion
Jan 2010
Completion
Dec 2010
Last update
Sep 12, 2011

Study contacts

Christopher B Harte, MA
principal investigator · University of Texas at Austin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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