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

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.

Study Overview

• Status: Suspended
• Conditions: Erectile Dysfunction; Hypoactive Sexual Desire Disorder

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A group of healthy volunteers from the general public. A group of patients who suffer from sexual disorder from a primary care clinic.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Healthy control subjects (n=20) age 21-65 who do not suffer from a psychiatric diagnosis or neurological damage, are under age, or are pregnant women
2; 20 patients who suffer from sexual disorder (reduced sexual desire or sexual function) from a sexual disorder clinic, age 21-65, without any other psychiatric disorder, neurological damage, are not under age or pregnant women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Brain Imaging data of DRD2 receptor occupancy during watching a sex videotape and neutral videotape	2 Brain imaging sessions a week apart

Secondary Outcome Measures

Outcome Measure	Time Frame
Questionnaire ratings of human sexuality, pleasure, and anticipatory reward	Taken during brain scans

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Ben-Gurion University of the Negev
• Investigators: Principal Investigator: Aviv M Weinstein, Ph.D, Hadasah Medical Organization, Jerusalem Israel

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: December 6, 2007
• First Submitted That Met QC Criteria: December 6, 2007
• First Posted (Estimate): December 7, 2007

Study Record Updates

• Last Update Posted (Estimate): June 10, 2010
• Last Update Submitted That Met QC Criteria: June 9, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: dopamine; Sex; brain imaging; sexual disorder
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunction, Physiological; Erectile Dysfunction; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: 281207HMO-CTIL; First 978[1].07