NCT02844985

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

August 17, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

3.8 years

First QC Date

June 17, 2016

Last Update Submit

January 8, 2020

Conditions

Sexual Addiction

Keywords

Sexual AddictionGenomicsPersonalityPolymorphism

Outcome Measures

Primary Outcomes (1)

  • Gene polymorphisms identified through polymerase chain reaction using fluorescent primers and restriction fragment length polymorphism analysis

    Assessed at Enrollment

Study Arms (2)

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

Interventions

No InterventionOTHER
Addict GroupControl Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Psychological Counseling Services

Scottsdale, Arizona, 85251, United States

Location

Gentle Path at The Meadows

Wickenburg, Arizona, 85390, United States

Location

Center for Healthy Sex

Los Angeles, California, 90025, United States

Location

Triune Therapy Group

Los Angeles, California, 90025, United States

Location

Pine Grove Behavioral Health and Addiction Services

Hattiesburg, Mississippi, 39402, United States

Location

Kavod Center

Rochester, New York, 14607, United States

Location

Center for Healthy Sexuality

Houston, Texas, 77057, United States

Location

Seattle Christian Counseling

Bellevue, Washington, 98004, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva specimens will be collected from all participants for genetic evaluation.

MeSH Terms

Conditions

Compulsive Sexual Behavior Disorder

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorSexual and Gender DisordersSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

July 26, 2016

Study Start

August 17, 2016

Primary Completion

June 1, 2020

Study Completion

December 1, 2021

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(8)