Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-03-06 @ 3:04 PM
Study NCT ID:
NCT00594659
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2008-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development and Efficacy Test of Computerized Treatment for Marijuana Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Alan.J.Budney@dartmouth.edu', 'phone': '855-290-2822', 'title': 'Alan J. Budney, PhD Principal Investigator', 'organization': 'Geisel School of Medicine at Dartmouth College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1-MET/CBT/CM', 'description': 'Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)\n\nPsychotherapy : Nine session treatment (wks 1-8 and wk 12)\n\n2x/wk urine drug testing\n\nContingency Management voucher program', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2-cMET/CBT/CM', 'description': 'Computer-delievered (c) MET/CBT/CM treatment\n\nComputerized Psychotherapy : Nine session computer delivered treatment\n\n2 times per week urine drug testing', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3-tMET', 'description': 'Motivational enhancement therapy\n\nMotivational enhancement therapy : Two session treatment\n\n2x/wk urine drug testing\n\nnon-contingent vouchers', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Consecutive Weeks of Marijuana Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-tMET/CBT/CM', 'description': 'Therapist delivered cognitive behavioral treatment\n\nPsychotherapy : Nine session treatment'}, {'id': 'OG001', 'title': '2-cMET/CBT/CM', 'description': 'Computerized Cognitive Behavioral treatment\n\nComputerized Psychotherapy : Nine session computer delivered treatment'}, {'id': 'OG002', 'title': '3-tMET', 'description': 'Motivational enhancement therapy\n\nMotivational enhancement therapy : Two session treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '4.21', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '1.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Pairwise comparison; non-parametric tests performed because of non-normal distribution', 'statisticalMethod': 'accelerated bootstrapping', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< .05', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'pairwise comparison; non-parametric analysis', 'statisticalMethod': 'accelerated bootstrapping', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'nonparametric pairwise comparison; non-normal distribution', 'statisticalMethod': 'accelerated bootstrapping', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From the start of treatment through the end of the active treatment period, i.e., 12 weeks.', 'description': 'Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.', 'unitOfMeasure': 'consecutive weeks of abstinence', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'PRIMARY', 'title': 'Point Prevalence Abstinence Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-tMET/CBT/CM', 'description': 'Therapist delivered cognitive behavioral treatment\n\nPsychotherapy : Nine session treatment'}, {'id': 'OG001', 'title': '2-cMET/CBT/CM', 'description': 'Computerized Cognitive Behavioral treatment\n\nComputerized Psychotherapy : Nine session computer delivered treatment'}, {'id': 'OG002', 'title': '3-tMET', 'description': 'Motivational enhancement therapy\n\nMotivational enhancement therapy : Two session treatment'}], 'classes': [{'title': 'End of Treatment (ETX) Abstinence Rate', 'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': '3-Months Post Treatment Abstinence Rate', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}]}]}, {'title': '6-months Post Treatment Abstinence Rate', 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}]}]}, {'title': '9-months Post Treatment Abstinence Rate', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'estimateComment': 'Slope and p-value above are for group 1: baseline to ETX. Group 3 vs. Group 1 baseline to ETX slope, p \\< 0.05. All other pairwise comparisons p \\> 0.05.', 'groupDescription': 'pairwise comparisons among groups across 4 follow-up timepoints', 'statisticalMethod': 'piecewise mixed model with logit link an', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Performed across all assessments.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 months (from the end of treatment to 9 months post-treatment).', 'description': 'Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).', 'unitOfMeasure': 'pecentage of participants abstinent', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1-MET/CBT/CM', 'description': 'Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)\n\nPsychotherapy : Nine session treatment (wks 1-8 and wk 12)\n\n2x/wk urine drug testing\n\nContingency Management voucher program'}, {'id': 'FG001', 'title': '2-cMET/CBT/CM', 'description': 'Computer-delievered (c) MET/CBT/CM treatment\n\nComputerized Psychotherapy : Nine session computer delivered treatment\n\n2 times per week urine drug testing'}, {'id': 'FG002', 'title': '3-tMET', 'description': 'Motivational enhancement therapy\n\nMotivational enhancement therapy : Two session treatment\n\n2x/wk urine drug testing\n\nnon-contingent vouchers'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Recruitment opened in November 2008 and closed in May 2011. Recruitment practices included newspaper and radio advertisements, flyers, and posters distributed in local businesses and agencies. The study took place at an outpatient psychiatry clinic.', 'preAssignmentDetails': 'Participants were excluded from trial prior to group assignment for at least one of the following:no evidence of marijuana use in at least 40 of the past 90 days prior to enrollment,participant met criteria for dependence on alcohol or illicit drugs,evidence of illicit drug use or K-2 use,interfering medical/psychiatric illness,or active refusal.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1-MET/CBT/CM', 'description': 'Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)\n\nNine weekly therapy sessions delivered in weeks 1-8 and week 12\n\n2 times per week urine drug testing\n\nContingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test.'}, {'id': 'BG001', 'title': '2-cMET/CBT/CM', 'description': 'Computer-delievered (c) MET/CBT/CM treatment\n\nComputer delivered nine MET/CBT sessions during weeks 1-8 and week 12. therapist delivered 3 brief supportive counseling sessions during weeks 1, 4, and 12.\n\n2 times per week urine drug testing.\n\nContingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test.'}, {'id': 'BG002', 'title': '3-tMET', 'description': 'Therapist delivered motivational enhancement therapy (tMET)\n\nTwo session treatment with sessions delivered during weeks 1 and 4.\n\nTwo times per week urine drug testing.\n\nNon-contingent incentives delivered for attending each urine testing appointment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '11.06', 'groupId': 'BG000'}, {'value': '34.87', 'spread': '11.07', 'groupId': 'BG001'}, {'value': '35', 'spread': '8.95', 'groupId': 'BG002'}, {'value': '34.85', 'spread': '10.52', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Point prevalence abstinence', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12.5', 'groupId': 'BG002'}, {'value': '25.5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Total percentage column is not accurate because it is automatically summed, which results in an invalid number.', 'unitOfMeasure': 'percentage of participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2008-01-07', 'resultsFirstSubmitDate': '2013-04-16', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-03', 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consecutive Weeks of Marijuana Abstinence', 'timeFrame': 'From the start of treatment through the end of the active treatment period, i.e., 12 weeks.', 'description': 'Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.'}, {'measure': 'Point Prevalence Abstinence Post Treatment', 'timeFrame': '9 months (from the end of treatment to 9 months post-treatment).', 'description': 'Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Marijuana', 'Treatment', 'Behavioral', 'Computer', 'Internet'], 'conditions': ['Marijuana Abuse and Dependence']}, 'descriptionModule': {'briefSummary': "More US residents are dependent on marijuana than on any other illicit drug, and the number enrolled in treatment for marijuana continues to increase such that it is now comparable to that for cocaine and heroin. This application seeks to advance the overarching goal to develop and disseminate cost-effective treatments for marijuana dependence that can address this growing problem.\n\nThe researchers' previous research suggests that an intervention comprising motivational enhancement, cognitive-behavioral, and contingency-management components (MET/CBT/CM) produces greater rates of successful and durable outcomes than has been demonstrated previously. However, three issues relevant to its efficacy and eventual dissemination must be confronted. First, the outcomes achieved can only be characterized as modest; many individuals do not respond to the treatment and relapse rates remain problematic. Second, access is limited by the availability of trained providers. Third, the cost of delivering the treatment is higher than more traditional outpatient interventions.\n\nTo address these issues, Specific Aim 1 is to develop and test a computer-assisted version of MET/CBT/CM. Computerized treatments have the potential to increase overall effectiveness of treatment services by increasing availability of and access to potent treatments, and by applying innovative technology to enhance outcomes. During Year 1, the intervention will be developed and pilot tested. An interactive program that showed promise in a previous trial for opioid dependence will be modified and enhanced to deliver individualized MET/CBT/CM using effective computer learning technologies. These technologies and access to the MET/CBT/CM program made available via the Internet between treatment sessions and after treatment ends have the potential to promote better learning and more use of coping skills, which in turn can improve outcomes. During Years 2-4 a randomized trial will provide an initial efficacy test of cMET/CBT/CM by comparing it with a brief treatment (MET) and with therapist-delivered MET/CBT/CM. Specific Aim 2 is to learn more about how behavioral treatments like MET/CBT/CM work by focusing on two putative mechanisms of action examined in prior trials: self-efficacy/coping skills and impulsivity/delay discounting. The experimental design will provide a unique opportunity to explore such mechanisms in a novel context- where the therapist is vs. is not a prominent part of the treatment.\n\nThe proposed project will address the objectives of NIDA's Behavioral and Integrative Treatment Development Program by providing research on technology-assisted treatment that attempts to make treatment delivery less complex, easier to access, and less costly - while retaining or improving its effectiveness. Findings will inform future studies designed to refine the technology and how it is applied; conduct more definitive effectiveness testing; test generality to other populations including adolescents; and to further advance translation to community settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Meet criteria for current DSM-IV diagnosis of marijuana abuse or dependence\n* Report use of marijuana on at least 40 of the past 90 days\n* Severe psychological distress\n\nExclusion Criteria:\n\n* Current dependence on alcohol or any other drug (except nicotine)\n* Participation in treatment for alcohol/drug problem\n* A legal status which will interfere with participation\n* Plans to move out of the area in the next 12 months\n* Living with someone who is already enrolled in the project\n* Not living within approximately 30 miles of the research site\n* Not being fluent in English'}, 'identificationModule': {'nctId': 'NCT00594659', 'briefTitle': 'Development and Efficacy Test of Computerized Treatment for Marijuana Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Development and Efficacy Test of Computerized Treatment for Marijuana Dependence', 'orgStudyIdInfo': {'id': '88268'}, 'secondaryIdInfos': [{'id': '1R01DA023526-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA023526-01', 'type': 'NIH'}, {'id': '1R01DA023526-02', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA023526-02', 'type': 'NIH'}, {'id': '1R01DA023526-03', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA023526-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Therapist delivered cognitive behavioral treatment', 'interventionNames': ['Behavioral: Psychotherapy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Computerized Cognitive Behavioral treatment', 'interventionNames': ['Behavioral: Computerized Psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Motivational enhancement therapy', 'interventionNames': ['Behavioral: Motivational enhancement therapy']}], 'interventions': [{'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Nine session treatment', 'armGroupLabels': ['1']}, {'name': 'Computerized Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Nine session computer delivered treatment', 'armGroupLabels': ['2']}, {'name': 'Motivational enhancement therapy', 'type': 'BEHAVIORAL', 'description': 'Two session treatment', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Geisel School of Medicine at Dartmouth', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Alan J Budney, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}