Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT00375102
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2006-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture and the Relaxation Response for Substance Abuse
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': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-12', 'studyFirstSubmitDate': '2006-09-11', 'studyFirstSubmitQcDate': '2006-09-11', 'lastUpdatePostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in self-reported substance craving rating from baseline to 10 week', 'timeFrame': 'baseline and 10 week follow up'}], 'secondaryOutcomes': [{'measure': 'Changes in anxiety level from baseline to 10 week', 'timeFrame': 'baseline and 10 week follow up'}, {'measure': 'Changes in quality of life from baseline to 10 week', 'timeFrame': 'baseline and 10 week follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acupuncture', 'relaxation response', 'homeless', 'veterans', 'randomized trials'], 'conditions': ['Substance Abuse']}, 'referencesModule': {'references': [{'pmid': '25187049', 'type': 'RESULT', 'citation': 'Chang BH, Sommers E. Acupuncture and relaxation response for craving and anxiety reduction among military veterans in recovery from substance use disorder. Am J Addict. 2014 Mar-Apr;23(2):129-36. doi: 10.1111/j.1521-0391.2013.12079.x. Epub 2013 Aug 30.'}, {'type': 'RESULT', 'citation': 'Chang BH, Elizabeth Sommers, Lawrence Herz, Acupuncture and relaxation response for substance use disorder recovery, Journal of Substance Use, 2010, 15(6): 390-401.'}]}, 'descriptionModule': {'briefSummary': 'This one-year pilot study has two specific aims: 1. to determine the feasibility of conducting a randomized controlled trial of acupuncture and the relaxation response for substance abuse among homeless veterans who are in a domiciliary care program, and 2. to collect and analyze pilot data to estimate the effect size for planning a future larger study to fully test the hypothesis of the effectiveness of acupuncture and the RR in reducing cravings for substances (alcohol and drugs), and the corollary effects on quality of life.', 'detailedDescription': 'Substance abuse is one of the most important risk factors for homelessness. A high proportion of the US homeless population are veterans, in large part due to the high prevalence of substance abuse among veterans. Thus, effective substance abuse treatment in veterans is essential to preventing homelessness, as well as reintegrating those already homeless. Traditional substance abuse therapies have shown inconsistent effectiveness, suggesting a need for alternative therapies. Acupuncture and the relaxation response (RR) are two commonly used complementary and alternative medicine modalities that have shown benefit in some studies. However, they have not been studied in homeless veterans who have completed detoxification treatment and are in early remission. Acupuncture and the RR share common features, yet have distinct differences. Acupuncture has to be administered by acupuncturists, while RR elicitation is a self-care strategy that can be learned and practiced anytime and anywhere. We propose a pilot study to determine the feasibility of conducting a three-arm randomized controlled trial on veterans in the Bedford Domiciliary Care for Homeless Veterans program and to collect pilot data for planning future larger studies to test the effectiveness of acupuncture and the RR in reducing substance craving and improving anxiety and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have a substance abuse or dependence problem of any type of substance\n2. Stay in the domiciliary for at least 10 weeks after the study entry to complete the study.\n\nExclusion Criteria:\n\n1. Schizophrenia or psychotic diagnoses\n2. Bleeding disorders (hemophilia or thrombocytopenia)\n3. An allergy to metals (needles).'}, 'identificationModule': {'nctId': 'NCT00375102', 'briefTitle': 'Acupuncture and the Relaxation Response for Substance Abuse', 'organization': {'class': 'FED', 'fullName': 'VA Boston Healthcare System'}, 'officialTitle': 'Acupuncture and the Relaxation Response for Homeless Veterans With Substance Abuse', 'orgStudyIdInfo': {'id': '1 EA-0000041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acup', 'description': 'Acupuncture', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'RR', 'description': 'Relaxation Response', 'interventionNames': ['Behavioral: Relaxation Response']}, {'type': 'NO_INTERVENTION', 'label': 'UC', 'description': 'Usual Care'}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'armGroupLabels': ['Acup']}, {'name': 'Relaxation Response', 'type': 'BEHAVIORAL', 'armGroupLabels': ['RR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01730', 'city': 'Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Bedford VAMC', 'geoPoint': {'lat': 42.49065, 'lon': -71.27617}}], 'overallOfficials': [{'name': 'Bei-Hung Chang, Sc.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Boston Healthcare System', 'class': 'FED'}, 'collaborators': [{'name': 'Samueli Institute for Information Biology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Health Research Scientist', 'investigatorFullName': 'Bei-Hung Chang', 'investigatorAffiliation': 'VA Boston Healthcare System'}}}}