Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-31 @ 4:12 AM
Study NCT ID:
NCT02044757
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2014-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Potentially Addictive Properties of Soda: A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013375', 'term': 'Substance Withdrawal Syndrome'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2014-01-22', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compliance with intervention to only drink water and unflavored milk during the SSB withdrawal phase', 'timeFrame': 'Days 6-8', 'description': 'Using measure of salivary caffeine, beverage recalls, and 24-hour dietary recalls, we will assess compliance.'}], 'primaryOutcomes': [{'measure': 'Symptoms of withdrawal', 'timeFrame': 'Days 1-3 and days 6-8', 'description': "Symptoms of withdrawal during the SSB withdrawal period (days 6-8) will be compared to symptoms of withdrawal during usual consumption period (days 1-3). Three measures are used to assess withdrawal symptoms: Griffiths' withdrawal scale, the relative reinforcing value of soda, and daily check in questions on well-being."}], 'secondaryOutcomes': [{'measure': 'Change in diet', 'timeFrame': 'Days 1-2, 6-8', 'description': 'Changes in diet will be assessed by 24-hour dietary recalls and beverage recalls'}, {'measure': 'Change in impulsivity', 'timeFrame': 'Days 1 and 8', 'description': 'Impulsivity will be assessed via the delayed discounting task'}, {'measure': 'Change in stress', 'timeFrame': 'Days 1 and 8', 'description': 'Stress will be assessed via salivary cortisol samples'}, {'measure': 'Change in preference for soda', 'timeFrame': 'Days 1-3, 6-8', 'description': 'Preference for soda will be measured through the Labeled Affective Magnitude Scale (LAMS) and daily check-in questions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Caffeine', 'Addiction', 'Withdrawal symptoms', 'Pediatric', 'Adolescent', 'Overweight'], 'conditions': ['Withdrawal Symptoms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB withdrawal period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Drinks more than 36 ounces of sugar-sweetened beverages per day\n* Speaks fluent English\n* Parent speaks English or Spanish\n* Lives in San Francisco Bay Area\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Taking medication to address mental health issues'}, 'identificationModule': {'nctId': 'NCT02044757', 'briefTitle': 'The Potentially Addictive Properties of Soda: A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'The Potentially Addictive Properties of Soda: A Feasibility Study', 'orgStudyIdInfo': {'id': '12-08545'}, 'secondaryIdInfos': [{'id': '6030sc', 'type': 'OTHER_GRANT', 'domain': 'UC Office of the President'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSB withdrawal', 'interventionNames': ['Behavioral: SSB withdrawal']}], 'interventions': [{'name': 'SSB withdrawal', 'type': 'BEHAVIORAL', 'description': 'During days 1-5, participants will drink the beverages they normally consume (no intervention). On days 6-8, participants will be instructed to drink only water and unflavored milk during the withdrawal period (days 6-8).', 'armGroupLabels': ['SSB withdrawal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital and Reasearch Center Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Kristine A Madsen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}