Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-01 @ 11:32 AM
Study NCT ID:
NCT04710095
Status:
COMPLETED
Last Update Posted:
2021-01-25
First Post:
2021-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perceived Alcohol Rewards and Risks Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Heavy Drinking Days', 'timeFrame': '4 weeks post intervention', 'description': 'Percent heavy drinking days defined as 5+ drinks for men and 4+ for women according to self-reported Timeline Follow Back (TLFB) data'}, {'measure': 'Neural Alcohol Cue Reactivity', 'timeFrame': 'Single time point immediately post intervention', 'description': 'Neural alcohol cue reactivity as measured by whole brain activation to alcohol taste cue vs. water taste cue using functional magnetic resonance imaging (fMRI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heavy Drinking']}, 'referencesModule': {'references': [{'pmid': '30556913', 'type': 'RESULT', 'citation': 'Grodin EN, Ray LA, MacKillop J, Lim AC, Karno MP. Elucidating the Effect of a Brief Drinking Intervention Using Neuroimaging: A Preliminary Study. Alcohol Clin Exp Res. 2019 Feb;43(2):367-377. doi: 10.1111/acer.13941. Epub 2019 Jan 20.'}, {'pmid': '31244697', 'type': 'RESULT', 'citation': 'Grodin EN, Lim AC, MacKillop J, Karno MP, Ray LA. An Examination of Motivation to Change and Neural Alcohol Cue Reactivity Following a Brief Intervention. Front Psychiatry. 2019 Jun 11;10:408. doi: 10.3389/fpsyt.2019.00408. eCollection 2019.'}, {'pmid': '34429151', 'type': 'DERIVED', 'citation': 'Meredith LR, Grodin EN, Karno MP, Montoya AK, MacKillop J, Lim AC, Ray LA. Preliminary study of alcohol problem severity and response to brief intervention. Addict Sci Clin Pract. 2021 Aug 24;16(1):54. doi: 10.1186/s13722-021-00262-6.'}]}, 'descriptionModule': {'briefSummary': 'The identification of mechanisms that underlie how people reduce or eliminate alcohol use is a critical public health issue. Understanding these mechanisms can inform how to effectively intervene with problem drinkers. Thus far it has been a challenge for the alcohol research field to find consistent empirical evidence in support of candidate mechanisms of behavior change. Scientific advancement in this area may be aided by longitudinal transdisciplinary research on the interplay between behavioral intervention, cognition, and brain activity to understand underlying processes of behavior change among heavy drinkers. This study employed a randomized 2-arm repeated measures design with a sample of non-treatment seeking adult heavy drinkers to examine changes in perceived reward value and risks of alcohol use as a mechanism of alcohol behavior change after a brief behavioral intervention. Participants were randomized to either a 1-session behavioral intervention or to an attention-matched control condition and immediately after completed an fMRI scan. The focus of this project is to examine if group differences in perceived alcohol reward value after the intervention mediates an intervention effect on reducing alcohol use in the 1 month following the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. engaged in regular heavy drinking, as indicated by consuming 5 or more drinks per occasion for men or 4 or more drinks per occasion for women at least 4 times in the month prior to enrollment\n2. a score of ≥ 8 on the Alcohol Use Disorder Identification Test (AUDIT)\n\nExclusion Criteria:\n\n1. under the age of 21\n2. currently receiving treatment for alcohol problems, history of treatment in the 30 days before enrollment, or currently seeking treatment\n3. a positive urine toxicology screen for any drug other than cannabis\n4. a lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder\n5. serious alcohol withdrawal symptoms\n6. history of epilepsy, seizures, or severe head trauma\n7. non-removable ferromagnetic objects in body\n8. claustrophobia\n9. pregnancy'}, 'identificationModule': {'nctId': 'NCT04710095', 'acronym': 'PARS', 'briefTitle': 'Perceived Alcohol Rewards and Risks Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Perceived Alcohol Reward Value and Risk: Neural Correlates and Treatment Effects', 'orgStudyIdInfo': {'id': 'IRB#15-000237'}, 'secondaryIdInfos': [{'id': 'R21AA023669', 'link': 'https://reporter.nih.gov/quickSearch/R21AA023669', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Brief Alcohol Intervention', 'description': 'A brief intervention consisting of a 30-45 minute individual face-to-face session based on the principles of motivational interviewing.', 'interventionNames': ['Behavioral: Brief Alcohol Intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'Attention-Matched Control Condition', 'description': 'Brief attention-matched control condition.', 'interventionNames': ['Behavioral: Control Condition']}], 'interventions': [{'name': 'Brief Alcohol Intervention', 'type': 'BEHAVIORAL', 'description': 'Brief alcohol intervention uses a motivational interviewing approach and covers the following components: giving information about the possible health risks associated with alcohol use, placing the responsibility for change on the individual, discussing the reasons for drinking and downsides of drinking, and setting a goal and change plan if the participant is receptive.', 'armGroupLabels': ['Brief Alcohol Intervention']}, {'name': 'Control Condition', 'type': 'BEHAVIORAL', 'description': 'The attention-matched control condition consisting of a 30-min video about astronomy.', 'armGroupLabels': ['Attention-Matched Control Condition']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lara A Ray, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Mitchell P Karno, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Lara Ray, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}