Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 10:49 PM
Study NCT ID:
NCT00032994
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2002-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse - 1
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 422}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2002-10'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2002-04-05', 'studyFirstSubmitQcDate': '2002-04-05', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug use'}, {'measure': 'Retention'}, {'measure': 'HIV risk behaviors'}, {'measure': 'Psychosocial functioning'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['substance use disorders'], 'conditions': ['Substance-Related Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ctndatashare.org/protocol-ctndatashare/new-protocols/nida-ctn-0005', 'label': 'Data Elements'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess Motivational Interviewing (MI) to improve treatment engagement and outcome in subjects seeking treatment for substance abuse.', 'detailedDescription': 'Participants seeking treatment at the participating CTPs will be randomly assigned to either "standard" or "MET/MI" treatment, with a 1- and 3-month follow-up. Primary outcome measures will include (1) treatment retention (e.g., number of sessions/weeks completed, the rate of patients completing 3 or more subsequent sessions, and (2) substance use (e.g., urinalyses, days of opioid, cocaine, marijuana, alcohol use, rates of abstinence). Secondary outcomes will include motivation, psychosocial functioning, HIV risk behaviors, treatment utilization, and patient satisfaction. Process assessments will include measures of the working alliance as well as therapist adherence/competence ratings which will evaluate how effectively MET/MI was implemented. Participating CTPs will implement one of two independent protocols, depending on which is the best suited or feasible for the intake procedures at their clinic. Thus, following an invitation to participate, explanation of the study, and provision of informed consent, patients would complete a brief assessment battery followed by either:1) Random assignment to 3 individual sessions of standard treatment (treatment as usual) at the program versus 3 individual sessions of MET; or 2) Random assignment to 1 individual standard assessment/evaluation session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals will be eligible for the protocol who: a)Are seeking outpatient treatment for any substance use disorder. b)Are 18 years of age or older. c)Are willing to participate in the protocol (e.g., to be randomized to treatment, be contacted for follow-up assessment, to have their sessions audiotaped). d)Are able to understand and provide written informed consent.\n\nExclusion Criteria:\n\nIndividuals will be excluded who: a)Are not sufficiently medically or psychiatrically stable to participate in outpatient treatment. b)Are seeking detoxification only, methadone maintenance, or residential inpatient treatment.'}, 'identificationModule': {'nctId': 'NCT00032994', 'briefTitle': 'Motivational Interviewing to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse - 1', 'nctIdAliases': ['NCT00015730'], 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Motivational Interviewing (MI) to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse', 'orgStudyIdInfo': {'id': 'NIDA-CTN-0005-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Behavior Therapy', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10007', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lower Eastside Service Center (LESC)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97402', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Willamette Family Treatment Services', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97292', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Changepoint - Cedar Hills Blvd', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97470', 'city': 'Roseburg', 'state': 'Oregon', 'country': 'United States', 'facility': 'ADAPT', 'geoPoint': {'lat': 43.2165, 'lon': -123.34174}}, {'zip': '23832', 'city': 'Chesterfield', 'state': 'Virginia', 'country': 'United States', 'facility': 'Chesterfield County CSB- Substance Abuse Services', 'geoPoint': {'lat': 37.37709, 'lon': -77.50582}}], 'overallOfficials': [{'name': 'Kathleen Carroll, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Connecticut Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kathleen Carroll, Ph.D.', 'oldOrganization': 'Yale University School of Medicine'}}}}