Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-28 @ 2:49 AM
Study NCT ID:
NCT02570360
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2015-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Treatment-as-usual in Substance Use Treatment Outcomes
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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Withdrawal Checklist: Change in physical and psychological withdrawal symptoms over the course of the intervention', 'timeFrame': 'up to 6 weeks', 'description': 'withdrawal symptoms will be assessed using the Withdrawal Checklist which asks participants to rate the severity of a variety physical and psychological symptoms over the past 48 hours. The total score on the Withdrawal Checklist will be used to provide an overall measured of withdrawal.'}], 'secondaryOutcomes': [{'measure': 'change in cortisol concentrations', 'timeFrame': 'measured before and after sessions (via saliva swab) during the first, third, and sixth weeks of the 6-week intervention'}, {'measure': 'change in endocannabinoid concentrations', 'timeFrame': 'measured before and after sessions (via single venipuncture)during the first, third, and sixth weeks of the 6-week intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Substance-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '31729933', 'type': 'RESULT', 'citation': 'Brellenthin AG, Crombie KM, Hillard CJ, Brown RT, Koltyn KF. Psychological and endocannabinoid responses to aerobic exercise in substance use disorder patients. Subst Abus. 2021;42(3):272-283. doi: 10.1080/08897077.2019.1680480. Epub 2019 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'The research study compares the substance abuse treatment outcomes (e.g., craving, withdrawal symptoms, rates of use, abstinence) of standard intensive outpatient care, with or without an added 6-wk aerobic exercise component. In addition, certain biomarkers associated with both exercise and substance use (e.g., endocannabinoids and cortisol) will be assessed. In a rolling admissions format over the course of a year, approximately 36 treatment-seeking substance users who are currently receiving Intensive Outpatient Treatment through a local Alcohol or Other Drug Abuse agency will be randomized to either receive 6 weeks aerobic exercise training in addition to standard care or standard care with 6 weekly laboratory visits to complete questionnaires (18 per group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intact cognitive status and ability to provide informed consent\n* ability to read and write in English sufficient to provide consent and complete study questionnaires\n* current diagnosis of a single or of multiple substance use disorders\n* currently enrolled in an Intensive Outpatient Treatment substance use program\n* desire to quit and to seek treatment for substance use\n* currently sedentary, not participating in any formal/structured exercise program\n\nExclusion Criteria:\n\n* a history or present diagnosis of severe depression, psychotic, or bipolar disorder\n* presence of cardiac disease or any other medical condition that would make engaging in exercise unsafe\n* Undergoing methadone treatment\n* chronic conditions such as cancer, diabetes, kidney disease, or autoimmune disorders\n* women who are pregnant or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT02570360', 'briefTitle': 'Exercise and Treatment-as-usual in Substance Use Treatment Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Comparative Effects of Exercise and Treatment-as-usual on Abstinence, Craving, and the Endocannabinoid System in Substance Users', 'orgStudyIdInfo': {'id': '2015-0710'}, 'secondaryIdInfos': [{'id': '1R36DA040140-01', 'link': 'https://reporter.nih.gov/quickSearch/1R36DA040140-01', 'type': 'NIH'}, {'id': 'A176000', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'EDUC\\KINESIOLOGY\\KINESIO', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'exercise', 'description': 'Participants will engage in their outpatient treatment program as-usual, but additionally complete 30mins of moderately intense aerobic exercise 3 times per week for 6 weeks. They will complete 6 weeks of treatment, totaling 18 sessions with exercise.', 'interventionNames': ['Behavioral: exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'treatment-as-usual', 'description': 'Participants will engage in their outpatient treatment program as-usual,but additionally complete 6 weekly, hour-long visits to complete questionnaires. They will complete 6 weeks of treatment (6 sessions total).', 'interventionNames': ['Behavioral: treatment-as-usual']}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'The EX participants will engage in supervised, individual treadmill exercise 3xs/wk at the UW Natatorium. Sessions will consist of a 5-minute warm-up followed by 30 minutes of a moderate to moderately-high intensity exercise and then finish with a 5-minute cool down. Questionnaires will be completed before and after exercise on a weekly basis.', 'armGroupLabels': ['exercise']}, {'name': 'treatment-as-usual', 'type': 'BEHAVIORAL', 'description': 'The control (standard care) participants will come to the UW-Natatorium on a weekly basis to complete questionnaires.', 'armGroupLabels': ['treatment-as-usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Angelique Brellenthin, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW-Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}