Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-30 @ 11:00 AM
Study NCT ID:
NCT04567394
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2020-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabis Use Disorder Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized 1:1 to the intervention or waitlist control. Participants who complete the 6 months of waitlist control will then have the opportunity to receive the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1077}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Tetrahydrocannabinol (Delta-9-THC-COOH) levels', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months', 'description': 'Urine THC levels (50ng/mL, 100ng/mL, 200ng/mL, 300ng/mL) will provide a biological measure for current cannabis use.'}, {'measure': 'Change in Past 30-Day Cannabis Use', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months', 'description': 'Past-30-day substance use (cannabis, alcohol, tobacco, other drugs) and consequences are measured using the Alcohol, Smoking and Substance Involvement Screening Test'}], 'secondaryOutcomes': [{'measure': 'Change in Environmental Risk Assessment', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months', 'description': 'Participants will report using the Ecological Momentary Assessment reporting about Craving (0=none-10= intense), Cannabis Use (0=none-10= a lot), Mood (0=very good-10= very depressed), and Stress (0=no stress-10 = very stressed) on a 10 point scale for each item'}, {'measure': 'Change in Young Adult Social Network Assessment', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months', 'description': "Participants report information on each their 3 closest friends, representing their egocentric network. Individual friend scores are totaled based on all 8 risky and prosocial items (2-9). Thus, each peer's score has a potential range from -32 to 32, with greater scores indicating a healthier relationship. The total peer network health scores is based on the sum of all 24 risky and prosocial items across all three friends. Assuming three peers per participant, total network quality scores may range from -96 to 96, with lower scores indicating greater network risk and higher scores indicating greater network protection."}, {'measure': 'Cost Measures', 'timeFrame': '6 months', 'description': 'Cost of intervention implementation will be compared to typical treatment cost for cannabis use disorder'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cannabis Use Disorder, Mild', 'Cannabis Use Disorder, Moderate', 'Cannabis Use Disorder, Severe']}, 'referencesModule': {'references': [{'pmid': '39019156', 'type': 'DERIVED', 'citation': 'Zaharakis N, Coatsworth JD, Riggs NR, Radford A, Rayburn S, Mennis J, Russell MA, Brown A, Mason MJ. Treating young adult cannabis use disorder with text message-delivered peer network counseling. Contemp Clin Trials. 2024 Sep;144:107635. doi: 10.1016/j.cct.2024.107635. Epub 2024 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a text-delivered counseling program to stop or reduce cannabis use among young adults (ages 18 to 25).', 'detailedDescription': 'After being informed about the study and potential risks, participants will complete online screening assessments. Those who are determined to be eligible via online screening will complete a urine drug screen to confirm eligibility. Once eligibility is confirmed, participants will be randomized either to the intervention group or to the wait-list control group. Those who are randomized to the intervention group will receive the 4-week text intervention via smartphone and complete assessments (including urine drug screens) at baseline, 1 month, 3 months, and 6 months. Those who are randomized to the wait-list control group will only complete the assessments (including urine drug screens) at baseline, 1 month, 3 months, and 6 months. Participants who are initially assigned to the wait-list control group can choose to receive the text intervention once their 6-month participation is complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 to 25 years old.\n2. use of cannabis three or more days during a typical week.\n3. a score of at least eight on the Cannabis Use Disorder Identification Test-Revised\n4. a urine specimen positive for cannabis metabolites.\n5. a score of at least two on the Mini International Neuropsychiatric Interview: Version 7.0.2 for DSM-V, Substance Use Disorder\n6. must live in Tennessee or Colorado\n\nExclusion Criteria:\n\n1. substance abuse treatment during the past three months.\n2. lack of access to a text-capable phone.\n3. unable or unwilling to commit to six months of follow-up.\n4. not fluent in English.'}, 'identificationModule': {'nctId': 'NCT04567394', 'briefTitle': 'Cannabis Use Disorder Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'The University of Tennessee, Knoxville'}, 'officialTitle': 'Treating Young Adult Cannabis Use Disorder with Text Message-Delivered Peer Network Counseling', 'orgStudyIdInfo': {'id': '1R01DA044206-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA044206-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants randomized to the Intervention group will complete questionnaires at baseline, 1 month, 3 months, and 6 months and will receive 4 weeks of the PNC-txt intervention.', 'interventionNames': ['Behavioral: Peer Network Counseling-txt']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control', 'description': 'Participants randomized to the waitlist control group will complete questionnaires at baseline, 1 month, 3 months, and 6 months.'}], 'interventions': [{'name': 'Peer Network Counseling-txt', 'type': 'BEHAVIORAL', 'otherNames': ['PNC-txt'], 'description': '4-week text counseling program', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80523', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado State University', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '37996', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Knoxvile', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Michael J Mason, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee, Knoxville'}, {'name': 'J. Douglas Coatsworth, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee, Knoxville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Tennessee, Knoxville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Colorado State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Mason', 'investigatorAffiliation': 'The University of Tennessee, Knoxville'}}}}