Effects of Yohimbine and Naltrexone on Sexual Function

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety and effectiveness of the drugs yohimbine and naltrexone in treating men with erectile dysfunction (ED) (the inability to achieve or maintain penile erection for satisfactory sexual performance).

ED is a medical and psychological problem that is usually associated with increased age. Evidence suggests that specific neurotransmitter systems are involved in the regulation of sexual function. Yohimbine and naltrexone are drugs that may influence these neurotransmitter systems. This study will use different doses of yohimbine and fixed doses of naltrexone to determine their effectiveness in treating ED.

Participants in this study will be screened with a medical history, physical examination, blood and urine tests, and an electrocardiogram (ECG). The study will consist of three outpatient visists.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Mental Health (NIMH)
• Treatments: Naltrexone; Yohimbine

Criteria

INCLUSION CRITERIA

Subjects must be medically healthy and free of mental illness, take no medication, and must report no problems with their sexual function. They are required to be sexually active, including successful penetrative sexual intercourse acts.

For assessments of sexual function before and after the study subjects are required to complete a detailed daily diary recording their erectile activity for 7 days before the first study session, and for 7 days after completion of the study.

EXCLUSION CRITERIA

Persons having taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function within 6 months prior to the study will be excluded.

Individuals will also be excluded if they have: a) evidence for an axis I psychiatric disorder (DSM-IV criteria), b) medical or neurological illnesses likely to affect physiology or anatomy, c) a history of drug (including BZDs) or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria), d) smokers, e) diagnosis of a sexual disorder, f) criminal history.

Persons must exhibit no or only moderate alcohol use. Persons with current or previous regular use ( more than 4 weeks) of BZDs and excessive use of alcohol (more than 8 ounces/day) in the past or presence are ineligible to participate, as such drug use confound the results.

Individuals beyond age 50 are excluded because subjects beyond age 50 have a far greater likelihood of showing subtile, albeit clinical irrelevant disturbances in erectile function.