Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

Tracking Information
First Submitted Date ICMJE	October 28, 2005
First Posted Date ICMJE	October 31, 2005
Last Update Posted Date	December 2, 2016
Study Start Date ICMJE	March 2002
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 26, 2007)	Social anxiety severity [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]; Alcohol use, quantity and frequency [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]; Drinking to cope, quantity and frequency [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]
Original Primary Outcome Measures ICMJE; (submitted: October 28, 2005)	Social anxiety severity; Alcohol use, quantity and frequency; Drinking to cope, quantity and frequency
Change History	Complete list of historical versions of study NCT00246441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 26, 2007)	Quality of life [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]; Depressive symptoms [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ]
Original Secondary Outcome Measures ICMJE; (submitted: October 28, 2005)	Quality of life; Depressive symptoms
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Official Title ICMJE	Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Brief Summary	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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Social Anxiety Disorder; Social Phobia; Alcohol Use Disorder; Alcohol Abuse; Alcohol Dependence
Intervention ICMJE	Drug: Paroxetine 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day; Drug: Placebo 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.
Study Arms	Experimental: 1 Paroxetine Intervention: Drug: Paroxetine; Placebo Comparator: 2 Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 1, 2016)	42
Original Enrollment ICMJE; (submitted: October 28, 2005)	50
Actual Study Completion Date	February 2008
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Meets DSM-IV criteria for current social anxiety disorder; Reports social anxiety in most situations (generalized type).; Treatment seeking for relief of social anxiety.; Meets DSM-IV criteria for current alcohol use disorder; Reads at the 6th grade level or above; Endorses using alcohol to cope with social anxiety either "very often" or "always."; Reports no prior medical alcohol detoxification; Willingness to be randomized to the placebo group; Willingness to attend 16 weekly medication management visits and one alcohol-related therapy session; Liebowitz Social Anxiety Scale Total score (modified version) of at least 60; 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. Exclusion Criteria: Abuse or dependence on drugs other than nicotine or marijuana in last 90 days; Current or past diagnosis of bipolar disorder or schizophrenia; Significant suicide risk as assessed by the SCID; Current use of psychotropic medications; Treatment seeking for alcohol problems; Any unstable medical condition that might interfere with safe participation in the trial; Elevated liver enzymes (3 x greater than normal levels); History of adverse reaction to paroxetine; History of failure to respond to adequate trial or dose of paroxetine for social phobia (60 mg/day for at least 6 weeks); History of heart problems or abnormal ECG recording; Pregnancy, nursing, or refusal to use effective birth control if sexually active and premenopausal; History of one or more alcohol detoxifications
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00246441
Other Study ID Numbers ICMJE	NIAAARAN013379; R01AA013379 ( U.S. NIH Grant/Contract ); NIH Grant R01 AA013379
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Medical University of South Carolina
Study Sponsor ICMJE	Medical University of South Carolina
Collaborators ICMJE	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators ICMJE	Principal Investigator: Carrie L Randall, PhD Medical University of South Carolina
PRS Account	Medical University of South Carolina
Verification Date	November 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP