Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT03922659
Status:
UNKNOWN
Last Update Posted:
2021-03-22
First Post:
2019-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006556', 'term': 'Heroin Dependence'}], 'ancestors': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of heroin dependence', 'timeFrame': '1 month', 'description': 'The rate of relapse of heroin dependence after discharge from hospital'}, {'measure': 'Recurrence of heroin dependence', 'timeFrame': '2 month', 'description': 'The rate of relapse of heroin dependence after discharge from hospital'}, {'measure': 'Recurrence of heroin dependence', 'timeFrame': '3 month', 'description': 'The rate of relapse of heroin dependence after discharge from hospital'}, {'measure': 'Recurrence of heroin dependence', 'timeFrame': '6 month', 'description': 'The rate of relapse of heroin dependence after discharge from hospital'}], 'secondaryOutcomes': [{'measure': 'Duration of abstinence', 'timeFrame': '6 months', 'description': 'The total time or period without any intake of heroin during follow-ups'}, {'measure': 'Heroin consumption', 'timeFrame': '2 weeks, 1 month, 2 months, 3 months and 6 months', 'description': 'Diaries of heroin intake in different time of the follow-ups'}, {'measure': 'Craving for heroin', 'timeFrame': '2 weeks, 1 month, 2 months, 3 months and 6 months', 'description': 'Craving assessment for heroin by Heroin Craving Questionnaire (HCQ) ranging from 0 to 175. Higher score of HCQ indicates more desire for heroin.'}, {'measure': 'Craving for heroin', 'timeFrame': '2weeks, 1 month, 2 months, 3 months and 6 months', 'description': 'Craving assessment by Visual Analogue Scale (VAS) for heroin desire ranging 0 to 10. Higher score indicates more desire for heroin.'}, {'measure': 'Cognitive assessment', 'timeFrame': '2 weeks, 1 month, 2 months, 3 months and 6 months', 'description': 'Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.'}, {'measure': 'Psychological assessment - Anxiety', 'timeFrame': '2 weeks, 1 month, 2 months, 3 months and 6 months', 'description': 'Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.'}, {'measure': 'Psychological assessment - Depression', 'timeFrame': '2 weeks, 1 month, 2 months, 3 months and 6 months', 'description': 'Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.'}, {'measure': 'Psychological assessment - Sleep', 'timeFrame': '2 weeks, 1 month, 2 months, 3 months and 6 months', 'description': 'Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heroin dependence, transcranial magnetic stimulation, cognitive behavioral therapy'], 'conditions': ['Heroin Dependence']}, 'referencesModule': {'references': [{'pmid': '19524780', 'type': 'BACKGROUND', 'citation': 'Phillips MR, Zhang J, Shi Q, Song Z, Ding Z, Pang S, Li X, Zhang Y, Wang Z. Prevalence, treatment, and associated disability of mental disorders in four provinces in China during 2001-05: an epidemiological survey. Lancet. 2009 Jun 13;373(9680):2041-53. doi: 10.1016/S0140-6736(09)60660-7.'}, {'pmid': '29189190', 'type': 'BACKGROUND', 'citation': 'Makani R, Pradhan B, Shah U, Parikh T. Role of Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment of Addiction and Related Disorders: A Systematic Review. Curr Drug Abuse Rev. 2017;10(1):31-43. doi: 10.2174/1874473710666171129225914.'}, {'pmid': '26995024', 'type': 'BACKGROUND', 'citation': 'Shen Y, Cao X, Tan T, Shan C, Wang Y, Pan J, He H, Yuan TF. 10-Hz Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex Reduces Heroin Cue Craving in Long-Term Addicts. Biol Psychiatry. 2016 Aug 1;80(3):e13-4. doi: 10.1016/j.biopsych.2016.02.006. Epub 2016 Feb 12. No abstract available.'}, {'pmid': '23709633', 'type': 'BACKGROUND', 'citation': 'Herremans SC, Vanderhasselt MA, De Raedt R, Baeken C. Reduced intra-individual reaction time variability during a Go-NoGo task in detoxified alcohol-dependent patients after one right-sided dorsolateral prefrontal HF-rTMS session. Alcohol Alcohol. 2013 Sep-Oct;48(5):552-7. doi: 10.1093/alcalc/agt054. Epub 2013 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Heroin dependence is one of most common substance dependence, which brings great burden on health worldwide. Heroin dependence may lead to immunosuppression and cognitive impairments. Once heroin dependence is developed, it will be difficult to recover and easy to relapse. Although many efforts had been made in the treatment of heroin dependence, the annual recurrence of heroin dependence with traditional therapies would be up to 90%. Repetitive transcranial magnetic stimulation (rTMS) on the dorsolateral prefrontal cortex (DLPFC) or cognitive behavioral therapy (CBT) each alone was reported to have some effect on preventing from relapse of substance dependence. In order to test whether combined therapy of high frequency rTMS (hf-rTMS) with CBT is better for preventing from relapse of heroin dependence, we recruit patients with heroin dependence to participate this study. The study is a factorial designed and the patients will be assigned into one of the following six groups randomly: (1) regular treatment (symptomatic treatment) with blank TMS; (2) regular treatment (RT) with blank TMS and CBT; (3) RT with right DLPFC hf-rTMS; (4) RT with right DLPFC hf-rTMS and CBT; (5) RT with left DLPFC hf-rTMS; (6) RT with left DLPFC hf-rTMS and CBT. TMS was given 5 days per week for total 2 weeks using uniform scheme (5 seconds of 10Hz stimulation per train, 30 trains per day with inter-train interval of 20 seconds). CBT will be given once per week for total 8 weeks. The patients will be followed up for 6 months. Recurrence of heroin dependence, duration of abstention, heroin/drug intake, craving for heroin and other cognitive psychological assessments will be recorded and compared among the 6 treatment groups and the efficacy of combined therapy of rTMS with CBT will be evaluated in our study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis as heroin dependence according to DSM-IV criteria\n* No definite history of neurological diseases and psychological problems\n* Volunteer to participate the study, cooperate to be followed up\n\nExclusion Criteria:\n\n* Acute withdrawal state and CIWA score \\> 9\n* With other neurological diseases and psychological problems\n* With ever brain trauma and damage\n* With other psychological medications or other substance dependence\n* With other contraindications to have transcranial magnetic stimulation'}, 'identificationModule': {'nctId': 'NCT03922659', 'acronym': 'THED', 'briefTitle': 'Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence', 'orgStudyIdInfo': {'id': '2019-12-TMSCBT-H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Regular treatment (symptomatic treatment) with blank TMS', 'description': 'Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation', 'interventionNames': ['Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular treatment (RT) with blank TMS and CBT', 'description': 'Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy', 'interventionNames': ['Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RT with right DLPFC hf-rTMS', 'description': 'Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS)', 'interventionNames': ['Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RT with right DLPFC hf-rTMS and CBT', 'description': 'Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)', 'interventionNames': ['Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RT with left DLPFC hf-rTMS', 'description': 'Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS)', 'interventionNames': ['Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RT with left DLPFC hf-rTMS and CBT', 'description': 'Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)', 'interventionNames': ['Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy']}], 'interventions': [{'name': 'Transcranial magnetic stimulation and Cognitive behavioral therapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy', 'armGroupLabels': ['RT with left DLPFC hf-rTMS', 'RT with left DLPFC hf-rTMS and CBT', 'RT with right DLPFC hf-rTMS', 'RT with right DLPFC hf-rTMS and CBT', 'Regular treatment (RT) with blank TMS and CBT', 'Regular treatment (symptomatic treatment) with blank TMS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ying Peng, MD, PhD', 'role': 'CONTACT', 'email': 'pengy2@mail.sysu.edu.cn', 'phone': '+86-13380051581'}, {'name': 'Hongxuan Wang, MD, PhD', 'role': 'CONTACT', 'email': 'wanghx8@mail.sysu.edu.cn', 'phone': '+86-13824498978'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director of Department of Neurology', 'investigatorFullName': 'Ying Peng', 'investigatorAffiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}}}}