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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569413
First Posted: December 7, 2007
Last Update Posted: June 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ben-Gurion University of the Negev
Information provided by:
Hadassah Medical Organization
  Purpose
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
Hypoactive Sexual Desire Disorder Erectile Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Combined Psycho-pharmacological and Brain Imaging Study of Human Sexuality

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Brain Imaging data of DRD2 receptor occupancy during watching a sex videotape and neutral videotape [ Time Frame: 2 Brain imaging sessions a week apart ]

Secondary Outcome Measures:
  • Questionnaire ratings of human sexuality, pleasure, and anticipatory reward [ Time Frame: Taken during brain scans ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569413


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
  More Information

Responsible Party: Prof. Roland Chisin, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00569413     History of Changes
Other Study ID Numbers: 281207HMO-CTIL
First 978[1].07
First Submitted: December 6, 2007
First Posted: December 7, 2007
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by Hadassah Medical Organization:
Sex
brain imaging
dopamine
sexual disorder

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Genital Diseases, Male
Mental Disorders