Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-29 @ 4:43 PM
Study NCT ID:
NCT01761032
Status:
COMPLETED
Last Update Posted:
2014-09-12
First Post:
2013-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gauging Of Light Dependent Experiences Through Neuroimaging (GOLDEN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-10', 'studyFirstSubmitDate': '2013-01-02', 'studyFirstSubmitQcDate': '2013-01-03', 'lastUpdatePostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Striatal dopaminergic efflux', 'timeFrame': 'Up to one hour post-administration of UVR', 'description': 'Determine if UVR induces striatal dopaminergic efflux is altered in compulsive tanners.'}], 'secondaryOutcomes': [{'measure': 'Striatal D2 receptors', 'timeFrame': '90 minutes prior to UVR administration', 'description': 'Basal striatal D2 receptors will be assessed in infrequent and compulsive tanners.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tanning', 'neuroimaging', 'dopamine', 'MRI', 'SPECT'], 'conditions': ['Compulsive and Infrequent Tanners']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ais.swmed.edu/redcap/surveys/?s=IJsQqx', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between ages 21-40\n* Tan at least twice weekly over the last year (Frequent Tanners)\n* Tan less than twice a week over the last year (Infrequent Tanners)\n* Meet modified DSM-IV criteria for Frequent Tanners\n\nExclusion Criteria:\n\n* Medications that effect brain functioning\n* Other medical or psychiatric disorders that may affect neural functioning.\n* Drug and Alcohol abuse or dependence\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01761032', 'acronym': 'GOLDEN', 'briefTitle': 'Gauging Of Light Dependent Experiences Through Neuroimaging (GOLDEN)', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Dopamine Response to Ultraviolet Light in Frequent and Infrequent Tanners', 'orgStudyIdInfo': {'id': 'STU 112011-012'}, 'secondaryIdInfos': [{'id': 'R21AR063018', 'link': 'https://reporter.nih.gov/quickSearch/R21AR063018', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infrequent tanners', 'description': 'Individuals who tan less than twice a week and do not meet modified DSM-IV criteria for tanning addiction.', 'interventionNames': ['Device: Tanning']}, {'label': 'Compulsive Tanners', 'description': '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', 'interventionNames': ['Device: Tanning']}], 'interventions': [{'name': 'Tanning', 'type': 'DEVICE', 'description': 'Participants will be placed under a tanning canopy for 4-10 minutes.', 'armGroupLabels': ['Compulsive Tanners', 'Infrequent tanners']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center at Dallas, Division on Addictions', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Bryon Adinoff, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern Medical Center at Dallas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}