Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 8:34 PM
Study NCT ID:
NCT03982433
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2019-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Internet-based Videoconferencing to Address Alcohol Use and Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'palfai@bu.edu', 'phone': '6173539345', 'title': 'Tibor Palfai, PhD', 'organization': 'Boston University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'no difference', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': '8 participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brief Pain Inventory Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '8 participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '2.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'past 7 days', 'description': 'BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst.\n\nPain interference is measures as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Brief Pain Inventory Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '8 participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'classes': [{'categories': [{'measurements': [{'value': '2.43', 'spread': '2.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'past 7 days', 'description': 'BPI consists of 11-point scale items that reflect pain severity and pain interference\n\nPain interference is measured as the mean of 7-items, each rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Alcohol Time Line Follow Back...Heavy Drinking Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '8 participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '4.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'past 30 days', 'description': 'number of heavy drinking episodes in the past 30 days', 'unitOfMeasure': 'number of episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Alcohol Time Line Follow Back...Average Drinks Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '8 participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '21.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'past 30 days', 'description': 'average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)', 'unitOfMeasure': 'drinks/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Client Satisfaction Questionnaire-8 [Modified]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '8 participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'classes': [{'categories': [{'measurements': [{'value': '29.29', 'spread': '2.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'past 30 days', 'description': 'Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment.\n\nThe possible range of scores is 8-32.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Perceptions of Treatment Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '8 participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'classes': [{'categories': [{'measurements': [{'value': '7.04', 'spread': '1.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'past 30 days', 'description': 'Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Goal Systems Assessment Battery-Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '8 participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'classes': [{'title': 'Pain-Value', 'categories': [{'measurements': [{'value': '3.25', 'spread': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Pain-Self-efficacy', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Pain-Monitoring', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'Pain-Planning', 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'past 30 days', 'description': 'Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Goal Systems Assessment Battery-Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '8 participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'classes': [{'title': 'Alcohol-Value', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Alcohol-Self-efficacy', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Alcohol-Monitoring', 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Alcohol-Planning', 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'past 30 days', 'description': 'Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': '8 participants assigned to receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruited from medical clinic and ongoing cohort'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'participants all receive the intervention\n\nMotivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'spread': '8.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Brief Pain Inventory (BPI)', 'classes': [{'title': 'pain severity', 'categories': [{'measurements': [{'value': '5.5', 'spread': '1.52', 'groupId': 'BG000'}]}]}, {'title': 'pain interference', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'description': 'BPI consists of 11-point scale items that reflect pain severity and pain interference\n\nAverage pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst.\n\nPain interference is measured as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst"\n\nScales range from 0 - 10', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heavy Drinking Episodes', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '5.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'description': 'Calendar-based measure of the number of heavy drinking episodes in the past 30 days.', 'unitOfMeasure': 'episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Drinks/week from Timeline FollowBack', 'classes': [{'categories': [{'measurements': [{'value': '36.50', 'spread': '18.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'description': 'Calendar-based measure of the number of drinks per week over the prior month. The average drinks per week is computed by (Total drinks/4.28)', 'unitOfMeasure': 'drinks/week', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-26', 'size': 101986, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-24T14:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants all undergo assessment and intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2019-05-14', 'resultsFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2019-06-10', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-21', 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Pain Inventory Pain Severity', 'timeFrame': 'past 7 days', 'description': 'BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst.\n\nPain interference is measures as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10'}, {'measure': 'Brief Pain Inventory Pain Interference', 'timeFrame': 'past 7 days', 'description': 'BPI consists of 11-point scale items that reflect pain severity and pain interference\n\nPain interference is measured as the mean of 7-items, each rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10'}, {'measure': 'Alcohol Time Line Follow Back...Heavy Drinking Episodes', 'timeFrame': 'past 30 days', 'description': 'number of heavy drinking episodes in the past 30 days'}, {'measure': 'Alcohol Time Line Follow Back...Average Drinks Per Week', 'timeFrame': 'past 30 days', 'description': 'average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)'}, {'measure': 'Client Satisfaction Questionnaire-8 [Modified]', 'timeFrame': 'past 30 days', 'description': 'Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment.\n\nThe possible range of scores is 8-32.'}, {'measure': 'Perceptions of Treatment Questionnaire', 'timeFrame': 'past 30 days', 'description': 'Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components.'}], 'secondaryOutcomes': [{'measure': 'Goal Systems Assessment Battery-Pain', 'timeFrame': 'past 30 days', 'description': 'Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.'}, {'measure': 'Goal Systems Assessment Battery-Alcohol', 'timeFrame': 'past 30 days', 'description': 'Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['Chronic Pain', 'Alcohol Use, Unspecified']}, 'referencesModule': {'references': [{'pmid': '39998790', 'type': 'DERIVED', 'citation': 'Palfai TP, Kratzer MPL, Taylor JL, Otis JD, Winter MR. Addressing Pain and Heavy Drinking among Patients in HIV-Care: A Pilot Study of an Integrated Telehealth Intervention. AIDS Behav. 2025 Jun;29(6):1930-1943. doi: 10.1007/s10461-025-04660-8. Epub 2025 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'This research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. This first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral.', 'detailedDescription': 'This study seeks to develop an integrated, behavioral video telehealth approach to address pain and heavy alcohol use among patients living with HIV and determine its feasibility and acceptability. Through an open pilot trial, this phase of this project will deliver an integrated alcohol-pain behavioral intervention to people living with HIV/AIDS (PLWHA) through videoconferencing. Intervention evaluation outcomes for this initial phase will include reduction of standard number of drinks per week, reduction in heavy drinking days, reduction of chronic pain severity and interference, ratings of patient satisfaction with treatment, and rate of treatment adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* engaged in HIV care, heavy drinking by more than 7/14 drinks per week (women/men) or by single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the Brief Pain Inventory (BPI) non-cancer related pain.\n\nExclusion Criteria:\n\n* psychoactive medication for pain or alcohol use for few than 2 months\n* history of bipolar disorder, schizophrenia, other psychotic disorder\n* current suicidal intent\n* prior history of alcohol withdrawal related seizures or delirium tremens\n* current behavioral treatment for pain or alcohol use\n* any scheduled surgery within next 6 months or acute life-threatening illness that requires treatment'}, 'identificationModule': {'nctId': 'NCT03982433', 'briefTitle': 'Internet-based Videoconferencing to Address Alcohol Use and Pain', 'organization': {'class': 'OTHER', 'fullName': 'Boston University Charles River Campus'}, 'officialTitle': 'Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care', 'orgStudyIdInfo': {'id': '4546'}, 'secondaryIdInfos': [{'id': 'UH2AA026192', 'link': 'https://reporter.nih.gov/quickSearch/UH2AA026192', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'participants all receive the intervention', 'interventionNames': ['Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain']}], 'interventions': [{'name': 'Motivation and Cognitive Behavioral Management for Alcohol and Pain', 'type': 'BEHAVIORAL', 'description': 'Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'General Clinical Research Unit, Boston University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Tibor P Palfai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University Charles River Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}