A Study of Gene Polymorphisms Associated With Specific Pr... | NCT02844985

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

NCT02844985

Sponsor

American Foundation for Addiction Research

Status

Unknown status

Last Update Posted

Jan 13, 2020Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Sexual Addiction

Interventions

No Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 17, 2016Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jun 17, 2016

First Submission Date that Met QC Criteria

Jul 22, 2016

First Posted Date

Jul 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2020

Last Update Posted Date

Jan 13, 2020Actual

Name	Class
University of Alberta	OTHER
University of Southern Mississippi	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other		Addict Group Control Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gene polymorphisms identified through polymerase chain reaction using fluorescent primers and restriction fragment length polymorphism analysis		Assessed at Enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Psychological Counseling Services		Scottsdale	Arizona	85251	United States
Gentle Path at The Meadows

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D016739	Behavior, Addictive
D003192	Compulsive Behavior
D007175	Impulsive Behavior
D001519	Behavior