Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT05864235
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2023-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Texting to Reduce Alcohol Misuse Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D063425', 'term': 'Binge Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The % of people screened to participants enrolled', 'timeFrame': '2 months', 'description': 'Online recruitment efficiency'}, {'measure': 'The % of participants who complete both 6- and 12-week web-based assessments', 'timeFrame': '12 weeks', 'description': 'Follow-up completion'}, {'measure': 'The % of SMS queries with valid responses', 'timeFrame': '6 weeks', 'description': 'Response rates to SMS queries'}, {'measure': 'The % of participants who at least agree that the SMS program helped them reduce their drinking', 'timeFrame': '12 weeks', 'description': 'A single question with response options: completely disagree to completely agree'}], 'secondaryOutcomes': [{'measure': '# Binge drinking days', 'timeFrame': '6-weeks', 'description': 'Count of binge drinking days using TLFB 30-day calendar'}, {'measure': 'Binge drinking days', 'timeFrame': '12-weeks', 'description': 'Count of binge drinking days using TLFB 30-day calendar'}, {'measure': 'Drinks per drinking day', 'timeFrame': '6-weeks', 'description': 'Mean drinks per drinking day using TLFB 30-day calendar'}, {'measure': 'Drinks per drinking day', 'timeFrame': '12-weeks', 'description': 'Mean drinks per drinking day using TLFB 30-day calendar'}, {'measure': '# Alcohol negative consequences', 'timeFrame': '6-weeks', 'description': 'B-YAACQ: 24 yes/no questions'}, {'measure': 'Alcohol negative consequences', 'timeFrame': '12-weeks', 'description': 'B-YAACQ: 24 yes/no questions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['young adults', 'binge drinking', 'text message'], 'conditions': ['Alcohol Consumption']}, 'descriptionModule': {'briefSummary': 'The primary aims of this project are to determine the feasibility and acceptability of recruiting and retaining young adult binge drinkers online and using text messaging to provide weekly Goal Support (GS) or weekly GS + Coaching for Context-specific Peer Support (CCPS) on alcohol consumption. The secondary aims will determine effect sizes for GS and GS+CCPS groups relative to controls on alcohol consumption at 6- and 12-weeks to inform design of an adequately-powered trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English reader\n* Owns a mobile phone with SMS\n* Hazardous alcohol consumption as measured by: "How many times in the past year have you had X or more drinks in a day?", where X is 5 for men and 4 for women, and a response of 1 or greater is considered at-risk\n* At least in contemplative stage of change for reducing alcohol consumption\n\nExclusion Criteria:\n\n* Currently enrolled or past enrollment in a 4-year college\n* Pregnant or pregnancy plans in the next 3-months\n* Current or planned treatment for alcohol or substance use disorder in next 3-months'}, 'identificationModule': {'nctId': 'NCT05864235', 'acronym': 'TRAM', 'briefTitle': 'Texting to Reduce Alcohol Misuse Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Texting to Reduce Alcohol Misuse Pilot Trial', 'orgStudyIdInfo': {'id': '67584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Each week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink.', 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Goal Support (GS)', 'description': 'Each week for 6-weeks, GS group participants will compete identical weekly text message assessments to the control group and receive further prompts and tailored feedback and support focused on weekly drinking limit goal commitment \\& confidence assessments and subsequently receive tailored feedback on goal success to either bolster future goal striving or reframe goal failure.', 'interventionNames': ['Behavioral: Control', 'Behavioral: Goal Support (GS)']}, {'type': 'EXPERIMENTAL', 'label': 'GS + Coaching for Context-specific Peer Support (CCPS)', 'description': 'Each week for 6-weeks, CCPS group participants will compete identical weekly text message assessments and feedback to GS plus additionally will receive weekly motivation and strategies to enlist peer support during drinking episodes.', 'interventionNames': ['Behavioral: Control', 'Behavioral: Goal Support (GS)', 'Behavioral: Coaching for Context-specific Peer Support (CCPS)']}], 'interventions': [{'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Each week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink.', 'armGroupLabels': ['Control', 'GS + Coaching for Context-specific Peer Support (CCPS)', 'Goal Support (GS)']}, {'name': 'Goal Support (GS)', 'type': 'BEHAVIORAL', 'description': 'Each week for 6-weeks, GS group participants will receive prompts and tailored feedback and support focused on weekly drinking limit goal commitment \\& confidence assessments and subsequently receive tailored feedback on goal success to either bolster future goal striving or reframe goal failure.', 'armGroupLabels': ['GS + Coaching for Context-specific Peer Support (CCPS)', 'Goal Support (GS)']}, {'name': 'Coaching for Context-specific Peer Support (CCPS)', 'type': 'BEHAVIORAL', 'description': 'Each week for 6-weeks, CCPS group participants will receive weekly motivation and strategies to enlist peer support during drinking episodes.', 'armGroupLabels': ['GS + Coaching for Context-specific Peer Support (CCPS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Brian Suffoletto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Brian Suffoletto', 'investigatorAffiliation': 'Stanford University'}}}}