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Gauging Of Light Dependent Experiences Through Neuroimaging (GOLDEN) (GOLDEN)

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ClinicalTrials.gov Identifier: NCT01761032
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : September 12, 2014
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date January 2, 2013
First Posted Date January 4, 2013
Last Update Posted Date September 12, 2014
Study Start Date January 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 3, 2013)
Striatal D2 receptors [ Time Frame: 90 minutes prior to UVR administration ]
Basal striatal D2 receptors will be assessed in infrequent and compulsive tanners.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gauging Of Light Dependent Experiences Through Neuroimaging (GOLDEN)
Official Title Dopamine Response to Ultraviolet Light in Frequent and Infrequent Tanners
Brief 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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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.
Condition Compulsive and Infrequent Tanners
Intervention Device: Tanning
Participants will be placed under a tanning canopy for 4-10 minutes.
Study Groups/Cohorts
  • Infrequent tanners
    Individuals who tan less than twice a week and do not meet modified DSM-IV criteria for tanning addiction.
    Intervention: 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
    Intervention: Device: Tanning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 3, 2013)
22
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Medications that effect brain functioning
  • Other medical or psychiatric disorders that may affect neural functioning.
  • Drug and Alcohol abuse or dependence
  • Pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01761032
Other Study ID Numbers STU 112011-012
R21AR063018 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor University of Texas Southwestern Medical Center
Collaborators National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Bryon Adinoff, M.D. UT Southwestern Medical Center at Dallas
PRS Account University of Texas Southwestern Medical Center
Verification Date September 2014