Smoking Cessation and Sexual Health in Men

What Was Tested

This registered phase 1 trial tested Therapeutic nicotine (patch, non-peptide).

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 had two arms (groups): Smoking Cessation (experimental) and Wait List Control (no intervention).

8-week nicotine patch regimen.

Smoking as usual.

The registry classes the interventions as drug.

More on the Plan

Extensive literature indicates that cigarette smoking is an independent risk factor for introducing erectile impairment in men.

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.

Who Took Part

80 planned participants were the target.

It was open to men only aged from 23 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Between the ages of 25 and 60. Proficient in English. Currently smoke at least 15 cigarettes per day for at least 5 years. Currently sexually active (sexual intercourse within the past 30 days). Committed to quit smoking.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2008-12 with completion listed for 2010-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Sexual functioning (time frame: Baseline, 4 weeks, 12 weeks).

It also tracked 1 secondary outcome, for example Cardiovascular health.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.