A Combined Psycho-pharmacological and Brain Imaging Study of Human Sexuality

Erectile Dysfunction Clinical Trial

Official title:

A Combined Psycho-pharmacological and Brain Imaging Study of Human Sexuality

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00569413
• Other study ID #: 281207HMO-CTIL
• Secondary ID: First 978[1].07
• Status: Suspended
• Phase: N/A
• First received: December 6, 2007
• Last updated: June 9, 2010
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: June 2010
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

The current study combines a molecular genetic perspective, self report and brain imaging to the study of human sexuality in control subjects and individuals from a sexual disorder clinic. The investigators hypothesize that the variability in components of the brain dopaminergic system expressed in the mesolimbic reward system can explain variability in human sexuality, especially in desire and pleasure associated with sex.

Description:

We intend to combine molecular genetics of the dopamine receptors (D2, D3 D4 and D5) and brain imaging using 11 C Raclopride in Positron Emission Tomography (PET). 11 C Raclopride is a ligand which binds to the dopamine receptor D2 and can measure dopamine release during pleasure or anticipatory reward associated with sex. The current proposal will measure changes in DRD2 receptor occupancy using 11 C Raclopride following explicit visual sexual desire cues in healthy control subjects and individuals who suffer from sexual dysfunction. This is in order to determine how individual genotypes modulate dopamine release in vivo in the human brain.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers and patients

• Age 21-65

• Male or female

Exclusion Criteria:

• Psychiatric diagnosis/psychosis

• Neurological damage associated with loss of consciousness

• Infectious disease HIV

• Herpes

• Syphilis

• Hyperactivity treated with ritalin

• Pregnant women

• Under age

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hypoactive Sexual Desire Disorder
• Sexual Dysfunctions, Psychological

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Ben-Gurion University of the Negev

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Imaging data of DRD2 receptor occupancy during watching a sex videotape and neutral videotape		2 Brain imaging sessions a week apart	Yes
Secondary	Questionnaire ratings of human sexuality, pleasure, and anticipatory reward		Taken during brain scans	No