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A Study of Gene Polymorphisms Associated With Specific Presentations of Sexual Addiction

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.
 
ClinicalTrials.gov Identifier: NCT02844985
Recruitment Status : Enrolling by invitation
First Posted : July 26, 2016
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
University of Alberta
University of Southern Mississippi
Information provided by (Responsible Party):
American Foundation for Addiction Research

Brief Summary:
The study is intended to identify gene polymorphisms significantly associated with specific behavioral- and preoccupation-typologies of sexual addiction, and to identify additional potential genetic markers of sexual addiction. Research subjects with sexual addiction will be identified from the out-patient and in-patient populations of the investigative sites. Research subjects in the Control Group will be identified from the general population and from the student body of selected colleges. Approximately 1100 subjects will be enrolled in the study. Anticipating 10% drop-out, this is intended to generate a population of approximately 500 men and women clinically diagnosed with sexual addiction, and approximately 500 healthy men and women who do not meet diagnostic criteria for sexual addiction nor have psychopathology who will serve as the control population.

Condition or disease Intervention/treatment
Sexual Addiction Other: No Intervention

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Genetic Markers in Sexual Addiction
Actual Study Start Date : August 17, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Addict Group
In-patient and out-patient adult men and women who meet diagnostic criteria for sexual addiction.
Other: No Intervention
Control Group
Individuals from the general community and college student populations who have no history of identifiable psychopathology.
Other: No Intervention



Primary Outcome Measures :
  1. Gene polymorphisms identified through polymerase chain reaction using fluorescent primers and restriction fragment length polymorphism analysis [ Time Frame: Assessed at Enrollment ]

Biospecimen Retention:   Samples With DNA
Saliva specimens will be collected from all participants for genetic evaluation.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Sexual Addict Group: individuals undergoing treatment for sexual addiction.

Control Group: individuals from general community who have no history of addiction or psychopathology

Criteria

Inclusion Criteria:

  • Sexual Addict Group

Age >= 18 years

Participating in sexual addiction treatment program

Sexual Addiction Screening Test--Revised (SAST-R) score >= 11

Meets at least 3 diagnostic criteria for sexual addiction

  • Control Group

Age >= 18 years

SAST-R score < 6

Exclusion Criteria:

  • Sexual Addiction Group

Serious mental illness

Significant cognitive impairment

  • Control Group

History of addiction

Current or previous Diagnostic and Statistical Manual (DSM-5) diagnosis

Serious mental illness

Significant cognitive impairment


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): NCT02844985


Locations
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United States, Arizona
Psychological Counseling Services
Scottsdale, Arizona, United States, 85251
Gentle Path at The Meadows
Wickenburg, Arizona, United States, 85390
United States, California
Center for Healthy Sex
Los Angeles, California, United States, 90025
Triune Therapy Group
Los Angeles, California, United States, 90025
United States, Mississippi
Pine Grove Behavioral Health and Addiction Services
Hattiesburg, Mississippi, United States, 39402
United States, New York
Kavod Center
Rochester, New York, United States, 14607
United States, Texas
Center for Healthy Sexuality
Houston, Texas, United States, 77057
United States, Washington
Seattle Christian Counseling
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
American Foundation for Addiction Research
University of Alberta
University of Southern Mississippi
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Responsible Party: American Foundation for Addiction Research
ClinicalTrials.gov Identifier: NCT02844985    
Other Study ID Numbers: AFAR 2016-001
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by American Foundation for Addiction Research:
Sexual Addiction
Genomics
Personality
Polymorphism
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior