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Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Social Anxiety Disorder
Social Phobia
Alcohol Use Disorder
Alcohol Abuse
Alcohol Dependence
Interventions Drug: Paroxetine
Drug: Placebo
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paroxetine Placebo
Hide Arm/Group Description

Paroxetine

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

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.

Period Title: Overall Study
Started 20 22
Completed 19 22
Not Completed 1 0
Arm/Group Title Paroxetine Placebo Total
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Paroxetine

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

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.

Total of all reporting groups
Overall Number of Baseline Participants 20 22 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 22 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
22
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 22 participants 42 participants
28  (6.5) 30  (8.3) 29  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 22 participants 42 participants
Female
9
  45.0%
11
  50.0%
20
  47.6%
Male
11
  55.0%
11
  50.0%
22
  52.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 22 participants 42 participants
20 22 42
1.Primary Outcome
Title Social Anxiety Severity
Hide Description 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.
Time Frame 16 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paroxetine Placebo
Hide Arm/Group Description:

Paroxetine

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

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.

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
87  (14.9) 93  (18.5)
2.Primary Outcome
Title Alcohol Use, Quantity and Frequency
Hide Description 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).
Time Frame 16 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paroxetine Placebo
Hide Arm/Group Description:

Paroxetine

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

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.

Overall Number of Participants Analyzed 20 22
Mean (Standard Error)
Unit of Measure: units on a scale
PDA .66  (.07) .65  (.07)
DDD 5.88  (1.02) 7.00  (1.48)
PHD .54  (.11) .55  (.13)
3.Primary Outcome
Title Drinking to Cope
Hide Description 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.
Time Frame 16 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paroxetine Placebo
Hide Arm/Group Description:

Paroxetine

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

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.

Overall Number of Participants Analyzed 20 22
Mean (Standard Error)
Unit of Measure: proportion of drinking days
.35  (.1) .21  (.04)
Time Frame 16 weeks
Adverse Event Reporting Description We used a 32 item side effect checklist and we asked subjects about all items on the list at each study visit.
 
Arm/Group Title Paroxetine Placebo
Hide Arm/Group Description

Paroxetine

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

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.

All-Cause Mortality
Paroxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/22 (0.00%) 
Hide Serious Adverse Events
Paroxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Paroxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/20 (70.00%)   8/22 (36.36%) 
Musculoskeletal and connective tissue disorders     
myoclonus   7/20 (35.00%)  1/22 (4.55%) 
Nervous system disorders     
tremor   9/20 (45.00%)  3/22 (13.64%) 
Reproductive system and breast disorders     
anorgasmia   11/20 (55.00%)  4/22 (18.18%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sarah Book
Organization: MUSC
Phone: 8437925200
EMail: booksw@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00246441    
Other Study ID Numbers: NIAAARAN013379
R01AA013379 ( U.S. NIH Grant/Contract )
First Submitted: October 28, 2005
First Posted: October 30, 2005
Results First Submitted: July 23, 2018
Results First Posted: September 27, 2018
Last Update Posted: September 27, 2018