Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

• ClinicalTrials.gov Identifier: NCT00246441
• Recruitment Status: Completed
• First Posted: October 30, 2005
• Results First Posted: September 27, 2018
• Last Update Posted: September 27, 2018
• Sponsor: Medical University of South Carolina
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Medical University of South Carolina

Tracking Information

• First Submitted Date: October 28, 2005
• First Posted Date: October 30, 2005
• Results First Submitted Date: July 23, 2018
• Results First Posted Date: September 27, 2018
• Last Update Posted Date: September 27, 2018
• Study Start Date: March 2002
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 25, 2018)

• Social Anxiety Severity [ Time Frame: 16 weeks treatment ]
  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.
• Alcohol Use, Quantity and Frequency [ Time Frame: 16 weeks treatment ]
  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).
• Drinking to Cope [ Time Frame: 16 weeks treatment ]
  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.

Original Primary Outcome Measures (submitted: October 28, 2005)

• Social Anxiety Severity
• Alcohol Use, Quantity and Frequency
• Drinking to cope, quantity and frequency

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: October 28, 2005)

• Quality of life
• Depressive symptoms

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Social Anxiety Disorder
• Social Phobia
• Alcohol Use Disorder
• Alcohol Abuse
• Alcohol Dependence

Intervention

• 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
  Other Name: paxil
• 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.
  Other Name: sugar pill

Study Arms

• Experimental: Paroxetine
  Active medication containing the drug Paroxetine
  Intervention: Drug: Paroxetine
• Placebo Comparator: Placebo
  A Placebo medication that appears just like the active medication but does not contain placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2016): 42
• Original Enrollment (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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00246441
• Other Study ID Numbers: NIAAARAN013379; R01AA013379 ( U.S. NIH Grant/Contract )
• 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: Medical University of South Carolina
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Carrie L Randall, PhD; Medical University of South Carolina

• PRS Account: Medical University of South Carolina
• Verification Date: September 2018