Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
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ClinicalTrials.gov Identifier: NCT00246441 |
Recruitment Status :
Completed
First Posted : October 30, 2005
Results First Posted : September 27, 2018
Last Update Posted : September 27, 2018
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Condition or disease | Intervention/treatment | Phase |
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Social Anxiety Disorder Social Phobia Alcohol Use Disorder Alcohol Abuse Alcohol Dependence | Drug: Paroxetine Drug: Placebo | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Paroxetine
Active medication containing the drug Paroxetine
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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
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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 |
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246441
United States, South Carolina | |
Medical University of South Carolina, Institute of Psychiatry | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Carrie L Randall, PhD | Medical University of South Carolina |
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 Key Record Dates |
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 |
Pharmacotherapy Self medication |
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 |