Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

NCT00246441 | Completed Phase 4 Results

• 2 other identifiers: NIAAARAN013379R01AA013379
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pharmacotherapy; Self medication

Outcome Measures

Primary Outcomes (3)

• Social Anxiety Severity

  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.

  16 weeks treatment

• Alcohol Use, Quantity and Frequency

  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).

  16 weeks treatment

• Drinking to Cope

  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.

  16 weeks treatment

Study Arms (2)

Paroxetine

EXPERIMENTAL

Active medication containing the drug Paroxetine

Drug: Paroxetine

Placebo

PLACEBO COMPARATOR

A Placebo medication that appears just like the active medication but does not contain placebo

Drug: Placebo

Interventions

Paroxetine DRUG

16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day

Also known as: paxil

Paroxetine

Placebo DRUG

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.

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Medical University of South Carolina, Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Phobia, Social; Alcoholism

Interventions

Paroxetine; Sugars

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Dr. Sarah Book
• Organization: MUSC

booksw@musc.edu

8437925200

Study Officials

• Carrie L Randall, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: March 1, 2002
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 27, 2018
• Results First Posted: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)