Smoking Cessation and Sexual Health in Men

NCT00833404 | Completed Phase 1

• 1 other identifier: 2008-06-0020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Smoking Cessation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sexual functioning

  Baseline, 4 weeks, 12 weeks

Secondary Outcomes (1)

• Cardiovascular health

  Baseline, 4 weeks, 12 weeks

Study Arms (2)

Smoking Cessation

EXPERIMENTAL

8-week nicotine patch regimen

Drug: Nicotine transdermal patch

Wait List Control

NO INTERVENTION

Smoking as usual

Interventions

Nicotine transdermal patch DRUG

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

Smoking Cessation

Eligibility Criteria

• Age: 23 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Christopher B Harte, MA

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

US (1)