Compulsive and Infrequent TannersGOLDENNCT01761032
Gauging Of Light Dependent Experiences Through Neuroimaging (GOLDEN)
An observational study of Compulsive and Infrequent Tanners, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
In the proposed study, the investigators will assess the brain's dopamine response to UVR light in individuals who use tanning beds both frequently and infrequently. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Compulsive and Infrequent Tanners
- What is being tested?
- Tanning
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2014
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be recruited though flyers and advertisements. Advertisements will be placed in college newspapers. Flyers will be placed on college campuses, and local Dallas stores and beauty salons.
Who may be able to join
- Between ages 21-40
- Tan at least twice weekly over the last year (Frequent Tanners)
- Tan less than twice a week over the last year (Infrequent Tanners)
- Meet modified DSM-IV criteria for Frequent Tanners
Who cannot join
- Medications that effect brain functioning
- Other medical or psychiatric disorders that may affect neural functioning.
- Drug and Alcohol abuse or dependence
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas, Division on Addictions
Dallas, Texas, 75390
About this study
Official title: Dopamine Response to Ultraviolet Light in Frequent and Infrequent Tanners
In the proposed study, the investigators will assess the brain's dopamine response to UVR light in individuals who use tanning beds both frequently and infrequently.
Read the detailed description
UV radiation has recently been classified as a known human carcinogen by the US Department of Health and Human Services. Nevertheless, the voluntary exposure to sunlight continues unabated despite progressively increasing rates of ultraviolet radiation (UVR)-induced illness and death, particularly skin cancer. An increasingly common form of UVR administration is through the use of indoor tanning salons. Almost 30 million Americans, including 20% of 18-39 year olds, visit indoor tanning salons each year. Frequent and excessive tanning, despite a growing understanding by those who tan of the morbidity and mortality associated with tanning, suggests that UVR may impart rewarding effects beyond the assumed cosmetic benefits. Recent studies, in fact, have shown that up to 40% of both frequent beach and salon tanners exhibit signs and symptoms consistent with an addictive disorder, including an inability to decrease their tanning frequencies, compulsive tanning, and/or continued tanning despite adverse consequences. As the mesostriatal dopaminergic pathway plays a key role in reward and addiction, the investigators propose to extend this novel finding by directly assessing the mesostriatal dopaminergic reward pathway in compulsive and infrequent tanners. This pathway plays a key role in the experience and integration of reward and alterations in this system have been observed in addicted populations. Specifically, 1) striatal dopamine is released in response to rewarding substances and experiences, 2) striatal dopamine2/3 receptor densities are lower in cocaine, alcohol, opioid, and nicotine dependent, as well as obese, subjects, and 3) reward-induced striatal dopamine efflux has been shown to be decreased in addicted, relative to non-addicted, subjects.
- Conditions
- Compulsive and Infrequent Tanners
- Being tested
- Tanning
- Keywords
- Tanning, neuroimaging, dopamine, MRI, SPECT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TanningDevice
Participants will be placed under a tanning canopy for 4-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Infrequent tanners | Individuals who tan less than twice a week and do not meet modified DSM-IV criteria for tanning addiction. Receives: Device: Tanning | |
| Compulsive Tanners | Individuals who tan more than 3 times per week in a tanning bed. Tanning must cause disruption in daily functioning. Must meet modified DSM-IV criteria for tanning addiction Receives: Device: Tanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Striatal dopaminergic efflux
Determine if UVR induces striatal dopaminergic efflux is altered in compulsive tanners.
Measured: Up to one hour post-administration of UVR
Secondary outcomes (1)
Striatal D2 receptors
Basal striatal D2 receptors will be assessed in infrequent and compulsive tanners.
Measured: 90 minutes prior to UVR administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compulsive and Infrequent TannersStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Bryon Adinoff, M.D., Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761032
- Sponsor's protocol ID
- STU 112011-012
- Other IDs
- R21AR063018
- Acronym
- GOLDEN
- Status last verified
- Sep 2014
- First submitted
- 2 Jan 2013
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Response to Ultraviolet Light in Frequent and Infrequent Tanners
- ClinicalTrials.gov ID
- NCT01761032
- Acronym / sponsor ID
- GOLDEN / STU 112011-012
- Conditions
- Compulsive and Infrequent Tanners
- Keywords
- Tanning, neuroimaging, dopamine, MRI, SPECT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Jan 2013 (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.
In the proposed study, the investigators will assess the brain's dopamine response to UVR light in individuals who use tanning beds both frequently and infrequently.
Detailed description
UV radiation has recently been classified as a known human carcinogen by the US Department of Health and Human Services. Nevertheless, the voluntary exposure to sunlight continues unabated despite progressively increasing rates of ultraviolet radiation (UVR)-induced illness and death, particularly skin cancer. An increasingly common form of UVR administration is through the use of indoor tanning salons. Almost 30 million Americans, including 20% of 18-39 year olds, visit indoor tanning salons each year. Frequent and excessive tanning, despite a growing understanding by those who tan of the morbidity and mortality associated with tanning, suggests that UVR may impart rewarding effects beyond the assumed cosmetic benefits. Recent studies, in fact, have shown that up to 40% of both frequent beach and salon tanners exhibit signs and symptoms consistent with an addictive disorder, including an inability to decrease their tanning frequencies, compulsive tanning, and/or continued tanning despite adverse consequences. As the mesostriatal dopaminergic pathway plays a key role in reward and addiction, the investigators propose to extend this novel finding by directly assessing the mesostriatal dopaminergic reward pathway in compulsive and infrequent tanners. This pathway plays a key role in the experience and integration of reward and alterations in this system have been observed in addicted populations. Specifically, 1) striatal dopamine is released in response to rewarding substances and experiences, 2) striatal dopamine2/3 receptor densities are lower in cocaine, alcohol, opioid, and nicotine dependent, as well as obese, subjects, and 3) reward-induced striatal dopamine efflux has been shown to be decreased in addicted, relative to non-addicted, subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrequent tanners | – | Device: TanningIndividuals who tan less than twice a week and do not meet modified DSM-IV criteria for tanning addiction. |
| Compulsive Tanners | – | Device: TanningIndividuals who tan more than 3 times per week in a tanning bed. Tanning must cause disruption in daily functioning. Must meet modified DSM-IV criteria for tanning addiction |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited though flyers and advertisements. Advertisements will be placed in college newspapers. Flyers will be placed on college campuses, and local Dallas stores and beauty salons.
Key inclusion criteria (4 listed)
- Between ages 21-40
- Tan at least twice weekly over the last year (Frequent Tanners)
- Tan less than twice a week over the last year (Infrequent Tanners)
- Meet modified DSM-IV criteria for Frequent Tanners
Key exclusion criteria (4 listed)
- Medications that effect brain functioning
- Other medical or psychiatric disorders that may affect neural functioning.
- Drug and Alcohol abuse or dependence
- Pregnancy
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 |
|---|---|---|
| TanningParticipants will be placed under a tanning canopy for 4-10 minutes. | Device | Compulsive Tanners, Infrequent tanners |
Primary outcome
Striatal dopaminergic efflux
Time frame: Up to one hour post-administration of UVR
Determine if UVR induces striatal dopaminergic efflux is altered in compulsive tanners.
1 secondary outcome
Striatal D2 receptors
Time frame: 90 minutes prior to UVR administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Related InfoLink provided by the sponsor.
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.
Bryon Adinoff, M.D. principal investigator
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compulsive and Infrequent Tanners, run by University of Texas Southwestern Medical Center at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Striatal dopaminergic efflux (time frame: Up to one hour post-administration of UVR). 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 12 Sep 2014.