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
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Active medication containing the 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
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.
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|