Viewing Study NCT01159535


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Study NCT ID: NCT01159535
Status: COMPLETED
Last Update Posted: 2016-08-15
First Post: 2010-07-07
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Mindfulness Based Relapse Prevention: Efficacy and Mechanisms
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055502', 'term': 'Secondary Prevention'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'swbowen@uw.edu', 'phone': '(206) 543-3452', 'title': 'Dr. Sarah Bowen', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness-Based Relapse Prevention (MBRP)', 'description': 'Mindfulness Based Relapse Prevention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.', 'otherNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Relapse Prevention (RP)', 'description': 'The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions were team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.\n\nRelapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)', 'otherNumAtRisk': 88, 'otherNumAffected': 0, 'seriousNumAtRisk': 88, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as Usual participants were enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants received ongoing support and monitoring by their continuing care providers on a regular basis.', 'otherNumAtRisk': 95, 'otherNumAffected': 0, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Number of Alcohol and Drug Use Days Out of Past 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Based Relapse Prevention (MBRP)', 'description': 'Mindfulness Based Relapse Prevention\n\nMindfulness Based Relapse Prevention: The MBRP intervention consisted of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.'}, {'id': 'OG001', 'title': 'Relapse Prevention (RP)', 'description': 'The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.'}, {'id': 'OG002', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as Usual included continuing care services (including attendance at Alcoholics Anonymous, Narcotics Anonymous, or other self-help groups) as recommended by their treatment providers.'}], 'classes': [{'title': 'Mean number of heavy drinking days', 'categories': [{'measurements': [{'value': '1.44', 'spread': '7.66', 'groupId': 'OG000'}, {'value': '3.89', 'spread': '12.17', 'groupId': 'OG001'}, {'value': '4.65', 'spread': '14.93', 'groupId': 'OG002'}]}]}, {'title': 'Mean number of drug use days', 'categories': [{'measurements': [{'value': '3.06', 'spread': '15.08', 'groupId': 'OG000'}, {'value': '6.09', 'spread': '19.05', 'groupId': 'OG001'}, {'value': '4.63', 'spread': '16.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days previous, assessed at 12-month follow-up', 'description': 'Self reported use of alcohol and or illicit substances over the previous 30 days', 'unitOfMeasure': 'number of days out of past 30', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness Based Relapse Prevention (MBRP)', 'description': 'Mindfulness Based Relapse Prevention\n\nMindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.'}, {'id': 'FG001', 'title': 'Relapse Prevention (RP)', 'description': 'The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.\n\nRelapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)'}, {'id': 'FG002', 'title': 'Treatment as Usual (TAU)', 'description': 'All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.\n\nTreatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '31'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness Based Relapse Prevention (MBRP)', 'description': 'Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.'}, {'id': 'BG001', 'title': 'Relapse Prevention (RP)', 'description': 'The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.\n\nRelapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)'}, {'id': 'BG002', 'title': 'Treatment as Usual', 'description': 'All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.\n\nTreatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.'}, {'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': '103', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '286', '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': '39.1', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '37.2', 'spread': '10.8', 'groupId': 'BG002'}, {'value': '38.5', 'spread': '10.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-01', 'studyFirstSubmitDate': '2010-07-07', 'resultsFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2010-07-07', 'lastUpdatePostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-01', 'studyFirstPostDateStruct': {'date': '2010-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Number of Alcohol and Drug Use Days Out of Past 30', 'timeFrame': '30 days previous, assessed at 12-month follow-up', 'description': 'Self reported use of alcohol and or illicit substances over the previous 30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['substance use', 'addiction', 'meditation', 'mindfulness', 'relapse prevention'], 'conditions': ['Substance Use Disorders']}, 'referencesModule': {'references': [{'pmid': '19904665', 'type': 'BACKGROUND', 'citation': 'Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084.'}, {'pmid': '20515211', 'type': 'BACKGROUND', 'citation': 'Witkiewitz K, Bowen S. Depression, craving, and substance use following a randomized trial of mindfulness-based relapse prevention. J Consult Clin Psychol. 2010 Jun;78(3):362-374. doi: 10.1037/a0019172.'}, {'pmid': '17300875', 'type': 'BACKGROUND', 'citation': 'Bowen S, Witkiewitz K, Dillworth TM, Marlatt GA. The role of thought suppression in the relationship between mindfulness meditation and alcohol use. Addict Behav. 2007 Oct;32(10):2324-8. doi: 10.1016/j.addbeh.2007.01.025. Epub 2007 Jan 23.'}, {'pmid': '16938074', 'type': 'BACKGROUND', 'citation': 'Bowen S, Witkiewitz K, Dillworth TM, Chawla N, Simpson TL, Ostafin BD, Larimer ME, Blume AW, Parks GA, Marlatt GA. Mindfulness meditation and substance use in an incarcerated population. Psychol Addict Behav. 2006 Sep;20(3):343-7. doi: 10.1037/0893-164X.20.3.343.'}, {'pmid': '20204916', 'type': 'BACKGROUND', 'citation': 'Chawla N, Collin S, Bowen S, Hsu S, Grow J, Douglass A, Marlatt GA. The mindfulness-based relapse prevention adherence and competence scale: development, interrater reliability, and validity. Psychother Res. 2010 Jul;20(4):388-97. doi: 10.1080/10503300903544257.'}, {'pmid': '20025383', 'type': 'BACKGROUND', 'citation': 'Collins SE, Chawla N, Hsu SH, Grow J, Otto JM, Marlatt GA. Language-based measures of mindfulness: initial validity and clinical utility. Psychol Addict Behav. 2009 Dec;23(4):743-9. doi: 10.1037/a0017579.'}, {'pmid': '31304887', 'type': 'DERIVED', 'citation': 'Somohano VC, Rehder KL, Dingle T, Shank T, Bowen S. PTSD Symptom Clusters and Craving Differs by Primary Drug of Choice. J Dual Diagn. 2019 Oct-Dec;15(4):233-242. doi: 10.1080/15504263.2019.1637039. Epub 2019 Jul 14.'}, {'pmid': '24647726', 'type': 'DERIVED', 'citation': 'Bowen S, Witkiewitz K, Clifasefi SL, Grow J, Chawla N, Hsu SH, Carroll HA, Harrop E, Collins SE, Lustyk MK, Larimer ME. Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):547-56. doi: 10.1001/jamapsychiatry.2013.4546.'}]}, 'descriptionModule': {'briefSummary': 'The broad, long-term objective of the proposed randomized clinical trial is to evaluate the efficacy, moderators and mechanisms of change of two cognitive-behavioral aftercare treatments for alcohol and other drug (AOD) use disorders in preventing AOD relapse compared to treatment as usual (TAU) offered in the community. The two cognitive-behavioral aftercare treatments are relapse prevention (RP) and Mindfulness-Based Relapse Prevention (MBRP), which integrates mindfulness meditation and RP aftercare components.', 'detailedDescription': 'Relapse to alcohol and other drug use (AOD) following treatment continues to be a costly problem for individual, society, and the substance abuse treatment community, and thus warrants the continued development of innovative and efficacious interventions designed to prevent AOD relapse. Mindfulness based relapse prevention (MBRP; Bowen, Chawla, \\& Marlatt, 2008) is one such promising intervention: it incorporates mindfulness meditation on the foundation of cognitive-behavioral relapse prevention (RP;Daley \\& Marlatt, 2006). RP is an established substance abuse treatment, yet as treatment developers, we believe RP can continue to be enhanced. Based on the results of an initial pilot trial, MBRP has demonstrated both feasibility and empirical promise as an aftercare treatment for AOD disorders in further enhancing long-term behavior change and reducing risk of relapse and related consequences. In the proposed study, MBRP and RP will be compared to the treatment as usual (TAU) as delivered by the Recovery Centers of King County (RCKC), in a population of individuals who have received community-based intensive inpatient (IP) or outpatient (IOP) treatment. RCKC is a community treatment agency that provides a range of addiction treatment services and has previously supported our efforts to recruit and retain sufficient numbers of the target population. The proposed study will examine whether structured mindfulness practice results in fewer AOD use days and fewer problems related to AOD use compared to TAU over a longer-term followup than in the previous pilot study. Given the high prevalence of AOD abuse in the population and the high rates of relapse following AOD treatment, the proposed research will provide a valuable next step in evaluating the efficacy of MBRP as an aftercare treatment for AOD disorders and in understanding the mechanisms of treatment efficacy. To our knowledge, no prior substance abuse treatment studies have evaluated the effect of adding a mindfulness-based component (e.g., MBRP) to an existing empirically supported treatment (i.e., RP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* completion or scheduled completion (i.e., within 2 weeks) of Inpatient or Intensive Outpatient treatment\n* fluency in English\n* enrollment in a substance abuse aftercare program\n* medical clearance by referring provider\n* willingness to accept random assignment to treatment condition\n\nExclusion Criteria:\n\n* already participated in the pilot MBRP trial conducted by this research team\n* participation in the comorbid disorders or relapse prevention groups offered at partner agency\n* comorbid psychosis (including schizophrenia, schizoaffective or other schizophreniform disorder)and/or dementia, acute suicidality/intent to harm others, severe cognitive impairment, and high risk of withdrawal or medical complications stemming from relapse which would require a higher level of care.'}, 'identificationModule': {'nctId': 'NCT01159535', 'acronym': 'MBRP', 'briefTitle': 'Mindfulness Based Relapse Prevention: Efficacy and Mechanisms', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Mindfulness Based Relapse Prevention: Efficacy and Mechanisms', 'orgStudyIdInfo': {'id': '31183-J'}, 'secondaryIdInfos': [{'id': '1R01DA025764-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA025764-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MBRP', 'description': 'The Mindfulness Based Relapse Prevention (MBRP) intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include mindfulness practices targeting craving, Negative affect, and reactivity, as well as discussion about how to implement practice into high-risk situations and in daily life.', 'interventionNames': ['Behavioral: Mindfulness Based Relapse Prevention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relapse Prevention (RP)', 'description': 'The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.', 'interventionNames': ['Behavioral: Relapse Prevention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as Usual', 'description': 'All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.', 'interventionNames': ['Behavioral: Treatment as Usual']}], 'interventions': [{'name': 'Mindfulness Based Relapse Prevention', 'type': 'BEHAVIORAL', 'otherNames': ['MBRP'], 'description': 'The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.', 'armGroupLabels': ['MBRP']}, {'name': 'Relapse Prevention', 'type': 'BEHAVIORAL', 'otherNames': ['RP'], 'description': 'intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)', 'armGroupLabels': ['Relapse Prevention (RP)']}, {'name': 'Treatment as Usual', 'type': 'BEHAVIORAL', 'otherNames': ['TAU'], 'description': 'All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.', 'armGroupLabels': ['Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Recovery Centers of King County', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Sarah Bowen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor/Co-Investigator', 'investigatorFullName': 'Seema Clifasefi', 'investigatorAffiliation': 'University of Washington'}}}}