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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Social Anxiety Disorder; Social Phobia; Alcohol Use Disorder; Alcohol Abuse; Alcohol Dependence	Drug: Paroxetine; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
• Study Start Date: March 2002
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: February 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Paroxetine; Active medication containing the drug Paroxetine	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
Placebo Comparator: Placebo; A Placebo medication that appears just like the active medication but does not contain placebo	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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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).
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, South Carolina

Medical University of South Carolina, Institute of Psychiatry

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

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

More Information

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT00246441
• Other Study ID Numbers: NIAAARAN013379; R01AA013379 ( U.S. NIH Grant/Contract )
• First Posted: October 30, 2005
• Results First Posted: September 27, 2018
• Last Update Posted: September 27, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Medical University of South Carolina:

Pharmacotherapy; Self medication

Additional relevant MeSH terms:

Disease; Alcoholism; Anxiety Disorders; Phobia, Social; Pathologic Processes; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Phobic Disorders; Paroxetine; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors