Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism - Full Text View

Purpose

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	Intervention	Phase
Social Anxiety Disorder Social Phobia Alcohol Use Disorder Alcohol Abuse Alcohol Dependence	Drug: Paroxetine Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism and Alcohol Abuse Anxiety

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Social anxiety severity [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]
Alcohol use, quantity and frequency [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]
Drinking to cope, quantity and frequency [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]
Depressive symptoms [ Time Frame: 16 weeks treatment; 6 month and 12 month follow-up interviews ] [ Designated as safety issue: No ]


Estimated Enrollment:	50
Study Start Date:	March 2002
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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
Placebo Comparator: 2 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.

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246441

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:	Carrie L. Randall, PhD, Principal Investigator, Medical University of South Carolina, Institute of Psychiatry
ClinicalTrials.gov Identifier:	NCT00246441 History of Changes
Other Study ID Numbers:	NIAAARAN013379 R01AA013379 NIH Grant R01 AA013379
Study First Received:	October 28, 2005
Last Updated:	November 17, 2009
Health Authority:	United States: Federal Government

Keywords provided by Medical University of South Carolina:


Pharmacotherapy Self medication

Additional relevant MeSH terms:


Disease Anxiety Disorders Alcoholism Phobic Disorders Pathologic Processes Mental Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced 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

ClinicalTrials.gov processed this record on September 29, 2016