{"protocolSection":{"identificationModule":{"nctId":"NCT00246441","orgStudyIdInfo":{"id":"NIAAARAN013379"},"secondaryIdInfos":[{"id":"R01AA013379","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01AA013379"}],"organization":{"fullName":"Medical University of South Carolina","class":"OTHER"},"briefTitle":"Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism","officialTitle":"Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism"},"statusModule":{"statusVerifiedDate":"2018-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2002-03"},"primaryCompletionDateStruct":{"date":"2008-02","type":"ACTUAL"},"completionDateStruct":{"date":"2008-02","type":"ACTUAL"},"studyFirstSubmitDate":"2005-10-28","studyFirstSubmitQcDate":"2005-10-28","studyFirstPostDateStruct":{"date":"2005-10-31","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-07-23","resultsFirstSubmitQcDate":"2018-09-25","resultsFirstPostDateStruct":{"date":"2018-09-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-09-25","lastUpdatePostDateStruct":{"date":"2018-09-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Medical University of South Carolina","class":"OTHER"},"collaborators":[{"name":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of the study is to determine whether an SSRI, paroxetine, improves social anxiety symptoms and alcohol use in individuals who drink to cope with social anxiety disorder.","detailedDescription":"Social anxiety disorder (also known as social phobia) is an Axis I anxiety disorder characterized by intense fear and avoidance of social or performance situations in which one might be scrutinized. Its onset is typically in the early teen years. It is the third most common mental disorder in the United States, exceeded in prevalence only by depression and alcoholism. Approximately 20% of the individuals with social anxiety disorder have alcohol problems. Anecdotal and empirical evidence suggests that alcohol is used by some socially anxious individuals to self-medicate anxiety symptoms, a practice that could lead to alcohol abuse and/or dependence. The proposed project further explores the self-medication hypothesis through the use of a double-blind, randomized, placebo-controlled clinical trial. Paroxetine (a selective serotonin reuptake inhibitor) is the drug to be used in the study. Individuals who drink alcohol to cope with social anxiety symptoms and who meet DSM-IV criteria for the dual-diagnoses of social anxiety disorder and alcohol use disorders will be enrolled in the trial. All individuals will be seeking treatment for social anxiety disorder. The treatment phase will last 16 weeks. Dosing will start at 20 mg/day (paroxetine or placebo) and will increase gradually to a maximum dose of 60 mg/day. Each week during treatment and at the end of the trial, assessments will be made with standard instruments to determine the effect of paroxetine (versus placebo) on social anxiety severity, alcohol use, and more specifically, the intentional use of alcohol to cope with social anxiety symptoms. Additionally, 6 month and 12 month follow-up interviews will be conducted. The overarching hypothesis is that because paroxetine will improve social anxiety severity, alcohol use and/or alcohol use for coping will also be reduced in the paroxetine-treated group."},"conditionsModule":{"conditions":["Social Anxiety Disorder","Social Phobia","Alcohol Use Disorder","Alcohol Abuse","Alcohol Dependence"],"keywords":["Pharmacotherapy","Self medication"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":42,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Paroxetine","type":"EXPERIMENTAL","description":"Active medication containing the drug Paroxetine","interventionNames":["Drug: Paroxetine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"A Placebo medication that appears just like the active medication but does not contain placebo","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Paroxetine","description":"16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day","armGroupLabels":["Paroxetine"],"otherNames":["paxil"]},{"type":"DRUG","name":"Placebo","description":"treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.","armGroupLabels":["Placebo"],"otherNames":["sugar pill"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Social Anxiety Severity","description":"Liebowitz Social Anxiety Scale (LSAS) - each of the two subscales, Fear and Avoidance, each have a maximum possible score of 72 (range 0 to 72). The total score ranges from 0 to 144. A higher score indicates higher severity of Social Anxiety Disorder.","timeFrame":"16 weeks treatment"},{"measure":"Alcohol Use, Quantity and Frequency","description":"Timeline Followback (TLFB), a validated calendar based instrument to assess number of standard drinks consumed on each day of the trial. Baseline measures were computed using past 30 days. From the TLFB, three measures were computed: 1. Proportion of days abstinent (PDA) (the number of days when no drinking occurred, divided by the number of days in the assessment period) (minimum is 0, maximum is 1) (higher score is better), 2. Drinks per drinking day (DDD) (the mean number of standard drinks consumed on a drinking day in the assessment period) (minimum is \\>0, maximum is infinity) (higher score is worse), 3. Proportion of Heavy Drinking Days (PHD) (the proportion of days each assessment period that a woman consumed 4 or more standard drinks/ man consumed 5 or more standard drinks) (minimum is 0, maximum is 1) (higher score is worse).","timeFrame":"16 weeks treatment"},{"measure":"Drinking to Cope","description":"Drinking days that were related to coping with Social Anxiety determined by the TLFB- the proportion of drinking days that were reported to be due to coping with social anxiety. Minimum value is 0, maximum value is 1 Higher is worse.","timeFrame":"16 weeks treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Meets DSM-IV criteria for current social anxiety disorder\n* Reports social anxiety in most situations (generalized type).\n* Treatment seeking for relief of social anxiety.\n* Meets DSM-IV criteria for current alcohol use disorder\n* Reads at the 6th grade level or above\n* Endorses using alcohol to cope with social anxiety either \"very often\" or \"always.\"\n* Reports no prior medical alcohol detoxification\n* Willingness to be randomized to the placebo group\n* Willingness to attend 16 weekly medication management visits and one alcohol-related therapy session\n* Liebowitz Social Anxiety Scale Total score (modified version) of at least 60\n* Endorses drinking at least 15 standard drinks in a typical 30 day period or reports drinking heavily (defined as greater-than-or-equal-to 4 standard drinks on one occasion for women; greater-than-or-equal-to 5 standard drinks on one occasion for men, respectively) on at least 2 days in a typical 30 day period.\n\nExclusion Criteria:\n\n* Abuse or dependence on drugs other than nicotine or marijuana in last 90 days\n* Current or past diagnosis of bipolar disorder or schizophrenia\n* Significant suicide risk as assessed by the SCID\n* Current use of psychotropic medications\n* Treatment seeking for alcohol problems\n* Any unstable medical condition that might interfere with safe participation in the trial\n* Elevated liver enzymes (3 x greater than normal levels)\n* History of adverse reaction to paroxetine\n* History of failure to respond to adequate trial or dose of paroxetine for social phobia (60 mg/day for at least 6 weeks)\n* History of heart problems or abnormal ECG recording\n* Pregnancy, nursing, or refusal to use effective birth control if sexually active and premenopausal\n* History of one or more alcohol detoxifications","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Carrie L Randall, PhD","affiliation":"Medical University of South Carolina","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Medical University of South Carolina, Institute of Psychiatry","city":"Charleston","state":"South Carolina","zip":"29425","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Paroxetine","description":"Paroxetine\n\nParoxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day"},{"id":"FG001","title":"Placebo","description":"Placebo\n\nPlacebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"22"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"22"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Paroxetine","description":"Paroxetine\n\nParoxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day"},{"id":"BG001","title":"Placebo","description":"Placebo\n\nPlacebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"42"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"42"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28","spread":"6.5"},{"groupId":"BG001","value":"30","spread":"8.3"},{"groupId":"BG002","value":"29","spread":"7.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"20"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"22"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"42"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Social Anxiety Severity","description":"Liebowitz Social Anxiety Scale (LSAS) - each of the two subscales, Fear and Avoidance, each have a maximum possible score of 72 (range 0 to 72). The total score ranges from 0 to 144. A higher score indicates higher severity of Social Anxiety Disorder.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"16 weeks treatment","groups":[{"id":"OG000","title":"Paroxetine","description":"Paroxetine\n\nParoxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day"},{"id":"OG001","title":"Placebo","description":"Placebo\n\nPlacebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"22"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"87","spread":"14.9"},{"groupId":"OG001","value":"93","spread":"18.5"}]}]}]},{"type":"PRIMARY","title":"Alcohol Use, Quantity and Frequency","description":"Timeline Followback (TLFB), a validated calendar based instrument to assess number of standard drinks consumed on each day of the trial. Baseline measures were computed using past 30 days. From the TLFB, three measures were computed: 1. Proportion of days abstinent (PDA) (the number of days when no drinking occurred, divided by the number of days in the assessment period) (minimum is 0, maximum is 1) (higher score is better), 2. Drinks per drinking day (DDD) (the mean number of standard drinks consumed on a drinking day in the assessment period) (minimum is \\>0, maximum is infinity) (higher score is worse), 3. Proportion of Heavy Drinking Days (PHD) (the proportion of days each assessment period that a woman consumed 4 or more standard drinks/ man consumed 5 or more standard drinks) (minimum is 0, maximum is 1) (higher score is worse).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"16 weeks treatment","groups":[{"id":"OG000","title":"Paroxetine","description":"Paroxetine\n\nParoxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day"},{"id":"OG001","title":"Placebo","description":"Placebo\n\nPlacebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"22"}]}],"classes":[{"title":"PDA","categories":[{"measurements":[{"groupId":"OG000","value":".66","spread":".07"},{"groupId":"OG001","value":".65","spread":".07"}]}]},{"title":"DDD","categories":[{"measurements":[{"groupId":"OG000","value":"5.88","spread":"1.02"},{"groupId":"OG001","value":"7.00","spread":"1.48"}]}]},{"title":"PHD","categories":[{"measurements":[{"groupId":"OG000","value":".54","spread":".11"},{"groupId":"OG001","value":".55","spread":".13"}]}]}]},{"type":"PRIMARY","title":"Drinking to Cope","description":"Drinking days that were related to coping with Social Anxiety determined by the TLFB- the proportion of drinking days that were reported to be due to coping with social anxiety. Minimum value is 0, maximum value is 1 Higher is worse.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"proportion of drinking days","timeFrame":"16 weeks treatment","groups":[{"id":"OG000","title":"Paroxetine","description":"Paroxetine\n\nParoxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day"},{"id":"OG001","title":"Placebo","description":"Placebo\n\nPlacebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"22"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":".35","spread":".1"},{"groupId":"OG001","value":".21","spread":".04"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"4","timeFrame":"16 weeks","description":"We used a 32 item side effect checklist and we asked subjects about all items on the list at each study visit.","eventGroups":[{"id":"EG000","title":"Paroxetine","description":"Paroxetine\n\nParoxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":14,"otherNumAtRisk":20},{"id":"EG001","title":"Placebo","description":"Placebo\n\nPlacebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":8,"otherNumAtRisk":22}],"otherEvents":[{"term":"anorgasmia","organSystem":"Reproductive system and breast disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":22}]},{"term":"myoclonus","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":22}]},{"term":"tremor","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":22}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Sarah Book","organization":"MUSC","email":"booksw@musc.edu","phone":"8437925200"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D000072861","term":"Phobia, Social"},{"id":"D000437","term":"Alcoholism"}],"ancestors":[{"id":"D010698","term":"Phobic Disorders"},{"id":"D001008","term":"Anxiety Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D019973","term":"Alcohol-Related Disorders"},{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D017374","term":"Paroxetine"},{"id":"D000073893","term":"Sugars"}],"ancestors":[{"id":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D002241","term":"Carbohydrates"}]}},"hasResults":true}