Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 3:30 AM
Study NCT ID:
NCT03363256
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2017-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web-based Addiction Treatment: Cultural Adaptation With American Indians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2017-11-30', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consecutive weeks of drug/alcohol abstinence', 'timeFrame': '12 weeks', 'description': 'Number of consecutive weeks of abstinence from drugs and alcohol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital therapeutics', 'Adaptation'], 'conditions': ['Substance Use Disorders']}, 'referencesModule': {'references': [{'pmid': '25022913', 'type': 'BACKGROUND', 'citation': 'Campbell AN, Turrigiano E, Moore M, Miele GM, Rieckmann T, Hu MC, Kropp F, Ringor-Carty R, Nunes EV. Acceptability of a web-based community reinforcement approach for substance use disorders with treatment-seeking American Indians/Alaska Natives. Community Ment Health J. 2015 May;51(4):393-403. doi: 10.1007/s10597-014-9764-1. Epub 2014 Jul 15.'}, {'pmid': '24700332', 'type': 'BACKGROUND', 'citation': 'Campbell AN, Nunes EV, Matthews AG, Stitzer M, Miele GM, Polsky D, Turrigiano E, Walters S, McClure EA, Kyle TL, Wahle A, Van Veldhuisen P, Goldman B, Babcock D, Stabile PQ, Winhusen T, Ghitza UE. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014 Jun;171(6):683-90. doi: 10.1176/appi.ajp.2014.13081055.'}, {'pmid': '37690525', 'type': 'DERIVED', 'citation': 'Campbell ANC, Rieckmann T, Pavlicova M, Choo TH, Molina K, McDonell M, West AE, Daw R, Marsch LA, Venner KL. Culturally tailored digital therapeutic for substance use disorders with urban Indigenous people in the United States: A randomized controlled study. J Subst Use Addict Treat. 2023 Dec;155:209159. doi: 10.1016/j.josat.2023.209159. Epub 2023 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to evaluate the preliminary efficacy of the Therapeutic Education System-Native Version (TES-NAV) (an efficacious web-delivered psychosocial intervention for substance use disorders adapted with American Indians/Alaska Natives \\[AI/AN\\]) to determine whether a future large-scale effectiveness trial is warranted. Specifically, a randomized controlled trial among urban AI/AN (N=80) attending outpatient addiction treatment services will be conducted to (1) estimate preliminary effect size of 12 weeks of TES-NAV on substance use disorder outcomes; (2) explore relevant moderators of TES-NAV outcomes; and (3) assess cultural factors that may correspond to variation in outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Identify as American Indian or Alaska Native\n* Recent alcohol or drug use\n* Within first 30 days of current outpatient treatment episode\n\nExclusion Criteria:\n\n* Planned treatment episode of less than 3 months\n* Insufficient ability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03363256', 'briefTitle': 'Web-based Addiction Treatment: Cultural Adaptation With American Indians', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Web-based Addiction Treatment: Cultural Adaptation With American Indians', 'orgStudyIdInfo': {'id': '#7555'}, 'secondaryIdInfos': [{'id': 'R34DA040831', 'link': 'https://reporter.nih.gov/quickSearch/R34DA040831', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAU+TES-NAV', 'description': 'Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN', 'interventionNames': ['Behavioral: TES-NAV', 'Behavioral: TAU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAU', 'description': 'Standard outpatient addiction treatment', 'interventionNames': ['Behavioral: TAU']}], 'interventions': [{'name': 'TES-NAV', 'type': 'BEHAVIORAL', 'description': 'Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN', 'armGroupLabels': ['TAU+TES-NAV']}, {'name': 'TAU', 'type': 'BEHAVIORAL', 'description': 'Standard outpatient addiction treatment', 'armGroupLabels': ['TAU', 'TAU+TES-NAV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97205', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Native American Rehabilitation Association of the Northwest, Inc.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Psychiatric Social Work', 'investigatorFullName': 'Aimee Campbell', 'investigatorAffiliation': 'New York State Psychiatric Institute'}}}}