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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Suspended

CT.gov ID

NCT00569413

Collaborator

Ben-Gurion University of the Negev (Other)

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder Erectile Dysfunction

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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Apr 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2011

Anticipated Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

Questionnaire ratings of human sexuality, pleasure, and anticipatory reward [Taken during brain scans]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hadassah Medical Organization
Ben-Gurion University of the Negev

Investigators

Principal Investigator: Aviv M Weinstein, Ph.D, Hadasah Medical Organization, Jerusalem Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00569413

Other Study ID Numbers:

281207HMO-CTIL
First 978[1].07

First Posted:

Dec 7, 2007

Last Update Posted:

Jun 10, 2010

Last Verified:

Jun 1, 2010

Keywords provided by , ,

Additional relevant MeSH terms:

Erectile Dysfunction

Sexual Dysfunctions, Psychological

Study Results

No Results Posted as of Jun 10, 2010