Text Size

Smoking Cessation and Sexual Health in Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Harte, Ph.D., University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT00833404
First received: January 30, 2009
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Smoking Cessation
 Drug: Nicotine transdermal patch
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Smoking Cessation on Sexual Health in Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Sexual functioning [ Time Frame: Baseline, 4 weeks, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular health [ Time Frame: Baseline, 4 weeks, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smoking Cessation
8-week nicotine patch regimen
 Drug: Nicotine 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).
Other Names:
  • Nicotine
  • Nicotine patch
No Intervention: Wait List Control
Smoking as usual

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.

  Eligibility

Ages Eligible for Study:   23 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833404

Locations
United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Christopher B Harte, MA University of Texas at Austin
  More Information

No publications provided

Responsible Party: Christopher Harte, Ph.D., Postdoctoral fellow, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT00833404     History of Changes
Other Study ID Numbers: 2008-06-0020
Study First Received: January 30, 2009
Last Updated: September 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
Smoking
Smoking Cessation
Quit Smoking
Stop Smoking
Nicotine Patch
 Nicotine Replacement Therapy
Sexual Functioning
Erectile Functioning
Sexual Health

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013