Sexual AddictionNCT02844985
A Study of Gene Polymorphisms Associated With Specific Presentations of Sexual Addiction
An observational study of Sexual Addiction, run by American Foundation for Addiction Research at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexual Addiction
- How many people
- 2,000 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Aug 2016to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Seattle Christian Counseling
Bellevue, Washington, 98004
Pine Grove Behavioral Health and Addiction Services
Hattiesburg, Mississippi, 39402
Center for Healthy Sexuality
Houston, Texas, 77057
Center for Healthy Sex
Los Angeles, California, 90025
Triune Therapy Group
Los Angeles, California, 90025
Kavod Center
Rochester, New York, 14607
Psychological Counseling Services
Scottsdale, Arizona, 85251
Gentle Path at The Meadows
Wickenburg, Arizona, 85390
About this study
Official title: Genetic Markers in Sexual Addiction
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.
- Conditions
- Sexual Addiction
- Being tested
- No Intervention
- Keywords
- Sexual Addiction, Genomics, Personality, Polymorphism
- Medical subject headings
- Compulsive Sexual Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Addict Group | In-patient and out-patient adult men and women who meet diagnostic criteria for sexual addiction. Receives: Other: No Intervention | |
| Control Group | Individuals from the general community and college student populations who have no history of identifiable psychopathology. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene polymorphisms identified through polymerase chain reaction using fluorescent primers and restriction fragment length polymorphism analysis
Measured: Assessed at Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start17 Aug 2016
- Primary completionJun 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Foundation for Addiction Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, University of Southern Mississippi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844985
- Sponsor's protocol ID
- AFAR 2016-001
- Status last verified
- Jan 2020
- First submitted
- 17 Jun 2016
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Markers in Sexual Addiction
- ClinicalTrials.gov ID
- NCT02844985
- Acronym / sponsor ID
- AFAR 2016-001
- Conditions
- Sexual Addiction
- Keywords
- Sexual Addiction, Genomics, Personality, Polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- American Foundation for Addiction ResearchUniversity, hospital or other
- Collaborators
- University of Alberta, University of Southern Mississippi
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Addict Group | – | Other: No InterventionIn-patient and out-patient adult men and women who meet diagnostic criteria for sexual addiction. |
| Control Group | – | Other: No InterventionIndividuals from the general community and college student populations who have no history of identifiable psychopathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- Sexual Addiction Group
- Serious mental illness
- Significant cognitive impairment
- Control Group
- History of addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention | Other | Addict Group, Control Group |
Primary outcome
Gene polymorphisms identified through polymerase chain reaction using fluorescent primers and restriction fragment length polymorphism analysis
Time frame: Assessed at Enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Addiction, run by American Foundation for Addiction Research at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene polymorphisms identified through polymerase chain reaction using fluorescent primers and restriction fragment length polymorphism analysis (time frame: Assessed at Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.